Trial Outcomes & Findings for Spectacles for Patients With Down Syndrome (NCT NCT03367793)

Last Updated: 2021-10-25

Results Overview

Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

two months

Results posted on

2021-10-25

Participant Flow

Participant milestones

Participant milestones
Measure	Clinical, Then Metric #1, Then Metric #2 Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Clinical, Then Metric #2, Then Metric #1 Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Clinical, Then Metric #2 Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Clinical, Then Metric #1 Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Metric #2, Then Clinical Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Metric #1, Then Clinical Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).
Initial Acuity at Dispense Visit (10min) STARTED	5	5	5	5	5	5
Initial Acuity at Dispense Visit (10min) COMPLETED	5	5	5	5	5	5
Initial Acuity at Dispense Visit (10min) NOT COMPLETED	0	0	0	0	0	0
Treatment 1 Dispense to 2 Months Wear STARTED	5	5	5	5	5	5
Treatment 1 Dispense to 2 Months Wear COMPLETED	5	5	5	5	5	5
Treatment 1 Dispense to 2 Months Wear NOT COMPLETED	0	0	0	0	0	0
Treatment 2 Dispense to 2 Months Wear STARTED	5	5	5	5	5	5
Treatment 2 Dispense to 2 Months Wear COMPLETED	5	5	4	5	5	5
Treatment 2 Dispense to 2 Months Wear NOT COMPLETED	0	0	1	0	0	0
Treatment 3 Dispense to 2 Months Wear STARTED	5	5	5	5	5	5
Treatment 3 Dispense to 2 Months Wear COMPLETED	5	5	5	5	5	5
Treatment 3 Dispense to 2 Months Wear NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Clinical, Then Metric #1, Then Metric #2 Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Clinical, Then Metric #2, Then Metric #1 Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Clinical, Then Metric #2 Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Clinical, Then Metric #1 Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Metric #2, Then Clinical Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Metric #1, Then Clinical Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).
Treatment 2 Dispense to 2 Months Wear Physician Decision	0	0	1	0	0	0

Baseline Characteristics

Spectacles for Patients With Down Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinical, Then Metric #1, Then Metric #2 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Clinical, Then Metric #2, Then Metric #1 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Clinical, Then Metric #2 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Clinical, Then Metric #1 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Metric #2, Then Clinical n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Metric #1, Then Clinical n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Total n=30 Participants Total of all reporting groups
Age, Continuous	32 years STANDARD_DEVIATION 9 • n=5 Participants	30 years STANDARD_DEVIATION 13 • n=7 Participants	34 years STANDARD_DEVIATION 9 • n=5 Participants	28 years STANDARD_DEVIATION 12 • n=4 Participants	24 years STANDARD_DEVIATION 4 • n=21 Participants	28 years STANDARD_DEVIATION 10 • n=8 Participants	29 years STANDARD_DEVIATION 10 • n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	15 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	15 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	7 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	23 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	4 Participants n=8 Participants	23 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	5 participants n=4 Participants	5 participants n=21 Participants	5 participants n=8 Participants	30 participants n=8 Participants
Adaptive Behavior Standard Score	74 Standard Score n=5 Participants	73 Standard Score n=7 Participants	59 Standard Score n=5 Participants	60 Standard Score n=4 Participants	57 Standard Score n=21 Participants	59 Standard Score n=8 Participants	60 Standard Score n=8 Participants
Binocular Distance Visual Acuity	0.30 logMAR STANDARD_DEVIATION .10 • n=5 Participants	0.48 logMAR STANDARD_DEVIATION 0.29 • n=7 Participants	0.40 logMAR STANDARD_DEVIATION 0.13 • n=5 Participants	0.38 logMAR STANDARD_DEVIATION 0.15 • n=4 Participants	0.46 logMAR STANDARD_DEVIATION 0.16 • n=21 Participants	0.30 logMAR STANDARD_DEVIATION 0.14 • n=8 Participants	0.39 logMAR STANDARD_DEVIATION 0.17 • n=8 Participants
Number presenting with spectacles	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	21 Participants n=8 Participants
Refractive Error Classification Myopia	5 Number of Eyes n=5 Participants	1 Number of Eyes n=7 Participants	4 Number of Eyes n=5 Participants	1 Number of Eyes n=4 Participants	8 Number of Eyes n=21 Participants	4 Number of Eyes n=8 Participants	23 Number of Eyes n=8 Participants
Refractive Error Classification Hyperopia	4 Number of Eyes n=5 Participants	6 Number of Eyes n=7 Participants	3 Number of Eyes n=5 Participants	4 Number of Eyes n=4 Participants	1 Number of Eyes n=21 Participants	3 Number of Eyes n=8 Participants	21 Number of Eyes n=8 Participants
Refractive Error Classification Mixed Astigmatism	1 Number of Eyes n=5 Participants	3 Number of Eyes n=7 Participants	3 Number of Eyes n=5 Participants	5 Number of Eyes n=4 Participants	0 Number of Eyes n=21 Participants	3 Number of Eyes n=8 Participants	15 Number of Eyes n=8 Participants
Refractive Error Classification Emmetropia	0 Number of Eyes n=5 Participants	0 Number of Eyes n=7 Participants	0 Number of Eyes n=5 Participants	0 Number of Eyes n=4 Participants	1 Number of Eyes n=21 Participants	0 Number of Eyes n=8 Participants	1 Number of Eyes n=8 Participants
Autorefraction Spherical Equivalent OD	-1.68 Diopters STANDARD_DEVIATION 4.53 • n=5 Participants	1.93 Diopters STANDARD_DEVIATION 3.07 • n=7 Participants	-3.73 Diopters STANDARD_DEVIATION 7.33 • n=5 Participants	0.98 Diopters STANDARD_DEVIATION 1.27 • n=4 Participants	-1.75 Diopters STANDARD_DEVIATION 4.37 • n=21 Participants	-5.23 Diopters STANDARD_DEVIATION 4.75 • n=8 Participants	-1.58 Diopters STANDARD_DEVIATION 4.88 • n=8 Participants
Autorefraction Spherical Equivalent OS	-2.03 Diopters STANDARD_DEVIATION 5.91 • n=5 Participants	1.95 Diopters STANDARD_DEVIATION 2.52 • n=7 Participants	-2.68 Diopters STANDARD_DEVIATION 6.81 • n=5 Participants	-0.05 Diopters STANDARD_DEVIATION 2.43 • n=4 Participants	-1.58 Diopters STANDARD_DEVIATION 4.55 • n=21 Participants	-3.53 Diopters STANDARD_DEVIATION 3.73 • n=8 Participants	-1.32 Diopters STANDARD_DEVIATION 4.59 • n=8 Participants
Autorefraction Cylinder OD	-1.45 Diopters STANDARD_DEVIATION 0.67 • n=5 Participants	-3.65 Diopters STANDARD_DEVIATION 1.43 • n=7 Participants	-2.65 Diopters STANDARD_DEVIATION 2.91 • n=5 Participants	-2.25 Diopters STANDARD_DEVIATION 1.08 • n=4 Participants	-1.50 Diopters STANDARD_DEVIATION 0.68 • n=21 Participants	-1.35 Diopters STANDARD_DEVIATION 0.68 • n=8 Participants	-2.14 Diopters STANDARD_DEVIATION 1.58 • n=8 Participants
Autorefraction Cylinder OS	-1.15 Diopters STANDARD_DEVIATION 0.68 • n=5 Participants	-3.60 Diopters STANDARD_DEVIATION 1.32 • n=7 Participants	-1.55 Diopters STANDARD_DEVIATION 1.81 • n=5 Participants	-2.10 Diopters STANDARD_DEVIATION 0.42 • n=4 Participants	-1.95 Diopters STANDARD_DEVIATION 1.45 • n=21 Participants	-2.05 Diopters STANDARD_DEVIATION 0.37 • n=8 Participants	-2.07 Diopters STANDARD_DEVIATION 1.30 • n=8 Participants

PRIMARY outcome

Timeframe: two months

Population: Spectacles from the clinical treatment method were not dispensed to one participant in the Metric #1, then Clinical, then Metric #2 group due to failure of the safety criteria required for dispense. This spectacle prescription resulted in visual acuity worse than 7 letters from the participant's presenting acuity to the study.

Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.

Outcome measures

Outcome measures
Measure	Clinical, Then Metric #1, Then Metric #2 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Clinical, Then Metric #2, Then Metric #1 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Clinical, Then Metric #2 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Clinical, Then Metric #1 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Metric #2, Then Clinical n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Metric #1, Then Clinical n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).
Adapted Visual Acuity Period 2 Treatment 1 Dispense to 2 Months Wear	0.256 logMAR Standard Deviation 0.110	0.440 logMAR Standard Deviation 0.240	0.356 logMAR Standard Deviation 0.149	0.284 logMAR Standard Deviation 0.089	0.300 logMAR Standard Deviation 0.163	0.364 logMAR Standard Deviation 0.048
Adapted Visual Acuity Period 3 Treatment 2 Dispense to 2 Months Wear	0.272 logMAR Standard Deviation 0.135	0.412 logMAR Standard Deviation 0.215	0.370 logMAR Standard Deviation 0.093	0.316 logMAR Standard Deviation 0.157	0.256 logMAR Standard Deviation 0.344	0.316 logMAR Standard Deviation 0.091
Adapted Visual Acuity Period 4 Treatment 3 Dispense to 2 Months Wear	0.288 logMAR Standard Deviation 0.100	0.424 logMAR Standard Deviation 00.238	0.320 logMAR Standard Deviation 0.117	0.276 logMAR Standard Deviation 0.140	0.216 logMAR Standard Deviation 0.119	0.372 logMAR Standard Deviation 0.091

SECONDARY outcome

Timeframe: 1 day

Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.

Outcome measures

Outcome measures
Measure	Clinical, Then Metric #1, Then Metric #2 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Clinical, Then Metric #2, Then Metric #1 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Clinical, Then Metric #2 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Clinical, Then Metric #1 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Metric #2, Then Clinical n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Metric #1, Then Clinical n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).
Initial Visual Acuity Treatment 1 Initial Dispense	0.28 logMAR Standard Deviation 0.14	0.43 logMAR Standard Deviation 0.25	0.34 logMAR Standard Deviation 0.22	0.28 logMAR Standard Deviation 0.13	0.29 logMAR Standard Deviation 0.35	0.33 logMAR Standard Deviation 0.09
Initial Visual Acuity Treatment 2 Initial Dispense	0.25 logMAR Standard Deviation 0.08	0.43 logMAR Standard Deviation 0.25	0.36 logMAR Standard Deviation 0.18	0.30 logMAR Standard Deviation 0.22	0.30 logMAR Standard Deviation 0.15	0.34 logMAR Standard Deviation 0.07
Initial Visual Acuity Treatment 3 Initial Dispense	0.31 logMAR Standard Deviation 0.40	0.44 logMAR Standard Deviation 0.24	0.40 logMAR Standard Deviation 0.16	0.32 logMAR Standard Deviation 0.18	0.28 logMAR Standard Deviation 0.14	0.40 logMAR Standard Deviation 0.05

SECONDARY outcome

Timeframe: two months

Population: For Period 3, one participant in group Metric #1, then Clinical, then Metric #2 did not receive the Clinical spectacle treatment because it failed the safety criteria for dispense. The clinical treatment for that participant reduced visual acuity greater than 7 letters from presenting acuity.

Total wear time of each pair of spectacles as measured objectively by a temperature sensor data logger mounted to the spectacle temple.

Outcome measures

Outcome measures
Measure	Clinical, Then Metric #1, Then Metric #2 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Clinical, Then Metric #2, Then Metric #1 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Clinical, Then Metric #2 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Clinical, Then Metric #1 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Metric #2, Then Clinical n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Metric #1, Then Clinical n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).
Spectacle Wear Time Period 4 Treatment 3 Dispense to 2 Months Wear	11.61 Hours Standard Deviation 6.05	13.32 Hours Standard Deviation 4.53	11.95 Hours Standard Deviation 4.18	9.47 Hours Standard Deviation 5.12	9.54 Hours Standard Deviation 4.34	11.31 Hours Standard Deviation 3.06
Spectacle Wear Time Period 2 Treatment 1 Dispense to 2 Months Wear	11.93 Hours Standard Deviation 4.95	13.15 Hours Standard Deviation 3.96	10.48 Hours Standard Deviation 4.08	9.81 Hours Standard Deviation 4.32	8.40 Hours Standard Deviation 4.29	11.62 Hours Standard Deviation 2.55
Spectacle Wear Time Period 3 Treatment 2 Dispense to 2 Months Wear	9.50 Hours Standard Deviation 5.50	12.68 Hours Standard Deviation 5.82	12.31 Hours Standard Deviation 4.74	9.67 Hours Standard Deviation 4.85	9.26 Hours Standard Deviation 4.17	11.25 Hours Standard Deviation 2.96

SECONDARY outcome

Timeframe: two months

Population: A single participant from group 'Metric #1, then Clinical, then Metric #2' was not dispensed the clinical treatment due to the treatment failing one of the safety criteria for dispense.

Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'Do you like wearing this pair of glasses?' Responses were coded 1 through 5 with 5 = large smile.

Outcome measures

Outcome measures
Measure	Clinical, Then Metric #1, Then Metric #2 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Clinical, Then Metric #2, Then Metric #1 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Clinical, Then Metric #2 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Clinical, Then Metric #1 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Metric #2, Then Clinical n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Metric #1, Then Clinical n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).
Spectacle Assessment Survey Question 1 Period 2 Treatment 1 Dispense to 2 Months Wear	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 2.0 to 5.0	5 score on a scale Interval 5.0 to 5.0
Spectacle Assessment Survey Question 1 Period 3 Treatment 2 Dispense to 2 Months Wear	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 4.0 to 5.0	5 score on a scale Interval 4.0 to 5.0	4 score on a scale Interval 4.0 to 5.0
Spectacle Assessment Survey Question 1 Period 4 Treatment 3 Dispense to 2 Months Wear	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	4 score on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: two months

Population: A single participant from group 'Metric #1, then Clinical, then Metric #2' was not dispensed the clinical treatment due to the treatment failing one of the safety criteria for dispense.

Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking far away?' Responses were coded 1 through 5 with 5 = large smile.

Outcome measures

Outcome measures
Measure	Clinical, Then Metric #1, Then Metric #2 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Clinical, Then Metric #2, Then Metric #1 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Clinical, Then Metric #2 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Clinical, Then Metric #1 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Metric #2, Then Clinical n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Metric #1, Then Clinical n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).
Spectacle Assessment Survey Question 2 Period 2 Treatment 1 Dispense to 2 Months Wear	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 4.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 4.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 4.0 to 5.0
Spectacle Assessment Survey Question 2 Period 3 Treatment 2 Dispense to 2 Months Wear	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	4.5 score on a scale Interval 4.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 4.0 to 5.0	4 score on a scale Interval 4.0 to 5.0
Spectacle Assessment Survey Question 2 Period 4 Treatment 3 Dispense to 2 Months Wear	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 4.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 4.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0

SECONDARY outcome

Timeframe: two months

Population: A single participant from group 'Metric #1, then Clinical, then Metric #2' was not dispensed the clinical treatment due to the treatment failing one of the safety criteria for dispense.

Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking up close?' Responses were coded 1 through 5 with 5 = large smile.

Outcome measures

Outcome measures
Measure	Clinical, Then Metric #1, Then Metric #2 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Clinical, Then Metric #2, Then Metric #1 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Clinical, Then Metric #2 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Clinical, Then Metric #1 n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #1, Then Metric #2, Then Clinical n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).	Metric #2, Then Metric #1, Then Clinical n=5 Participants Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).
Spectacle Assessment Survey Question 3 Period 2 Treatment 1 Dispense to 2 Months Wear	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 4.0 to 5.0	5 score on a scale Interval 4.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0
Spectacle Assessment Survey Question 3 Period 3 Treatment 2 Dispense to 2 Months Wear	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 4.5 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0
Spectacle Assessment Survey Question 3 Period 4 Treatment 3 Dispense to 2 Months Wear	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 4.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 5.0 to 5.0	5 score on a scale Interval 4.0 to 5.0

Adverse Events

Clinical

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Metric #1

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Metric #2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Clinical n=29 participants at risk Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.	Metric #1 n=30 participants at risk Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).	Metric #2 n=30 participants at risk Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).
Eye disorders Vision complaint related to comparison with earlier randomized treatment or habitual spectacles	24.1% 7/29 • Number of events 7 • Adverse event data were collected from the time of dispense of the first treatment through follow up of the final dispensed treatment (6 months total). Parents/guardians of participants were contacted by phone one day and one week after each new treatment was dispensed to inquire whether participants were having any difficulty with the glasses. At every visit, participants and their family member were asked if there had been any medical or medication changes since the last visit and if they had any concerns about the spectacles or any new ocular or visual complaints. Reports of glasses needing a fit adjustment were not considered AEs.	3.3% 1/30 • Number of events 1 • Adverse event data were collected from the time of dispense of the first treatment through follow up of the final dispensed treatment (6 months total). Parents/guardians of participants were contacted by phone one day and one week after each new treatment was dispensed to inquire whether participants were having any difficulty with the glasses. At every visit, participants and their family member were asked if there had been any medical or medication changes since the last visit and if they had any concerns about the spectacles or any new ocular or visual complaints. Reports of glasses needing a fit adjustment were not considered AEs.	6.7% 2/30 • Number of events 2 • Adverse event data were collected from the time of dispense of the first treatment through follow up of the final dispensed treatment (6 months total). Parents/guardians of participants were contacted by phone one day and one week after each new treatment was dispensed to inquire whether participants were having any difficulty with the glasses. At every visit, participants and their family member were asked if there had been any medical or medication changes since the last visit and if they had any concerns about the spectacles or any new ocular or visual complaints. Reports of glasses needing a fit adjustment were not considered AEs.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Symptoms	0.00% 0/29 • Adverse event data were collected from the time of dispense of the first treatment through follow up of the final dispensed treatment (6 months total). Parents/guardians of participants were contacted by phone one day and one week after each new treatment was dispensed to inquire whether participants were having any difficulty with the glasses. At every visit, participants and their family member were asked if there had been any medical or medication changes since the last visit and if they had any concerns about the spectacles or any new ocular or visual complaints. Reports of glasses needing a fit adjustment were not considered AEs.	13.3% 4/30 • Number of events 5 • Adverse event data were collected from the time of dispense of the first treatment through follow up of the final dispensed treatment (6 months total). Parents/guardians of participants were contacted by phone one day and one week after each new treatment was dispensed to inquire whether participants were having any difficulty with the glasses. At every visit, participants and their family member were asked if there had been any medical or medication changes since the last visit and if they had any concerns about the spectacles or any new ocular or visual complaints. Reports of glasses needing a fit adjustment were not considered AEs.	6.7% 2/30 • Number of events 3 • Adverse event data were collected from the time of dispense of the first treatment through follow up of the final dispensed treatment (6 months total). Parents/guardians of participants were contacted by phone one day and one week after each new treatment was dispensed to inquire whether participants were having any difficulty with the glasses. At every visit, participants and their family member were asked if there had been any medical or medication changes since the last visit and if they had any concerns about the spectacles or any new ocular or visual complaints. Reports of glasses needing a fit adjustment were not considered AEs.

Additional Information

Dr. Heather Anderson, Study PI

Ohio State University College of Optometry

Phone: 614-247-5825

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place