Trial Outcomes & Findings for Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation (NCT NCT01515475)

Last Updated: 2019-07-16

Results Overview

At the 36-month visit, each subject's condition will be classified as either failure or not a failure. The primary analytic approach will be a treatment group comparison of the proportion meeting failure criteria at 36-months using the Fisher's exact test. The participant met failure criteria if ANY of the following criteria (except strabismus surgery prior to the 3-year outcome exam) were met during testing at the 3-year examination both with and without trial frames (without prism or bifocal), and the criteria was confirmed by a retest 1. Any measurable manifest strabismus in primary gaze at distance or at near not correctable with distance refractive correction alone 2. Strabismus surgery prior to the 36-month exam 3. Distance VA below age norms in either eye 4. ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye 5. ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye 6. Stereoacuity measured at near below age normal values

Recruitment status

COMPLETED

Study phase

Target enrollment

249 participants

Primary outcome timeframe

36 months after randomization

Results posted on

2019-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	Glasses- Older Cohort Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Overall Study STARTED	61	58	65	65
Overall Study COMPLETED	41	43	53	53
Overall Study NOT COMPLETED	20	15	12	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Glasses- Older Cohort Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Overall Study Lost to Follow-up	20	15	12	12

Baseline Characteristics

Family history of amblyopia was not available for 2 (3%) participants in glasses group and 3 (5%) in observation group in the Older Cohort. Family history of amblyopia was not reported for 3 participants (5%) in glasses group and 2 participants (3%) in observation group in the Younger Cohort.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glasses- Older Cohort n=61 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=58 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=65 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=65 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Total n=249 Participants Total of all reporting groups
Age, Categorical <=18 years	61 Participants n=61 Participants	58 Participants n=58 Participants	65 Participants n=65 Participants	65 Participants n=65 Participants	249 Participants n=249 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=61 Participants	0 Participants n=58 Participants	0 Participants n=65 Participants	0 Participants n=65 Participants	0 Participants n=249 Participants
Age, Categorical >=65 years	0 Participants n=61 Participants	0 Participants n=58 Participants	0 Participants n=65 Participants	0 Participants n=65 Participants	0 Participants n=249 Participants
Age, Customized 1 Year	0 Participants n=61 Participants	0 Participants n=58 Participants	42 Participants n=65 Participants	42 Participants n=65 Participants	84 Participants n=249 Participants
Age, Customized 2 Years	0 Participants n=61 Participants	0 Participants n=58 Participants	23 Participants n=65 Participants	23 Participants n=65 Participants	46 Participants n=249 Participants
Age, Customized 3 Years	19 Participants n=61 Participants	20 Participants n=58 Participants	0 Participants n=65 Participants	0 Participants n=65 Participants	39 Participants n=249 Participants
Age, Customized 4 Years	31 Participants n=61 Participants	30 Participants n=58 Participants	0 Participants n=65 Participants	0 Participants n=65 Participants	61 Participants n=249 Participants
Age, Customized 5 Years	11 Participants n=61 Participants	8 Participants n=58 Participants	0 Participants n=65 Participants	0 Participants n=65 Participants	19 Participants n=249 Participants
Sex: Female, Male Female	38 Participants n=61 Participants	32 Participants n=58 Participants	33 Participants n=65 Participants	35 Participants n=65 Participants	138 Participants n=249 Participants
Sex: Female, Male Male	23 Participants n=61 Participants	26 Participants n=58 Participants	32 Participants n=65 Participants	30 Participants n=65 Participants	111 Participants n=249 Participants
Race/Ethnicity, Customized Asian	2 Participants n=61 Participants	0 Participants n=58 Participants	1 Participants n=65 Participants	0 Participants n=65 Participants	3 Participants n=249 Participants
Race/Ethnicity, Customized Black/African American	12 Participants n=61 Participants	14 Participants n=58 Participants	2 Participants n=65 Participants	3 Participants n=65 Participants	31 Participants n=249 Participants
Race/Ethnicity, Customized Hispanic	13 Participants n=61 Participants	7 Participants n=58 Participants	7 Participants n=65 Participants	8 Participants n=65 Participants	35 Participants n=249 Participants
Race/Ethnicity, Customized White	34 Participants n=61 Participants	35 Participants n=58 Participants	53 Participants n=65 Participants	52 Participants n=65 Participants	174 Participants n=249 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=61 Participants	1 Participants n=58 Participants	2 Participants n=65 Participants	2 Participants n=65 Participants	5 Participants n=249 Participants
Race/Ethnicity, Customized Unknown/Not reported	0 Participants n=61 Participants	1 Participants n=58 Participants	0 Participants n=65 Participants	0 Participants n=65 Participants	1 Participants n=249 Participants
Family History of Amblyopia	16 Participants n=59 Participants • Family history of amblyopia was not available for 2 (3%) participants in glasses group and 3 (5%) in observation group in the Older Cohort. Family history of amblyopia was not reported for 3 participants (5%) in glasses group and 2 participants (3%) in observation group in the Younger Cohort.	17 Participants n=55 Participants • Family history of amblyopia was not available for 2 (3%) participants in glasses group and 3 (5%) in observation group in the Older Cohort. Family history of amblyopia was not reported for 3 participants (5%) in glasses group and 2 participants (3%) in observation group in the Younger Cohort.	21 Participants n=62 Participants • Family history of amblyopia was not available for 2 (3%) participants in glasses group and 3 (5%) in observation group in the Older Cohort. Family history of amblyopia was not reported for 3 participants (5%) in glasses group and 2 participants (3%) in observation group in the Younger Cohort.	20 Participants n=63 Participants • Family history of amblyopia was not available for 2 (3%) participants in glasses group and 3 (5%) in observation group in the Older Cohort. Family history of amblyopia was not reported for 3 participants (5%) in glasses group and 2 participants (3%) in observation group in the Younger Cohort.	74 Participants n=239 Participants • Family history of amblyopia was not available for 2 (3%) participants in glasses group and 3 (5%) in observation group in the Older Cohort. Family history of amblyopia was not reported for 3 participants (5%) in glasses group and 2 participants (3%) in observation group in the Younger Cohort.
Family History of Strabismus	11 Participants n=59 Participants • Family history of strabismus was not available for 2 (3%) participants in glasses group and 1 (2%) in the observation group in the Older Cohort. Family history of strabismus was not reported for 2 participants (3%) in glasses group in the Younger Cohort.	16 Participants n=57 Participants • Family history of strabismus was not available for 2 (3%) participants in glasses group and 1 (2%) in the observation group in the Older Cohort. Family history of strabismus was not reported for 2 participants (3%) in glasses group in the Younger Cohort.	26 Participants n=63 Participants • Family history of strabismus was not available for 2 (3%) participants in glasses group and 1 (2%) in the observation group in the Older Cohort. Family history of strabismus was not reported for 2 participants (3%) in glasses group in the Younger Cohort.	25 Participants n=65 Participants • Family history of strabismus was not available for 2 (3%) participants in glasses group and 1 (2%) in the observation group in the Older Cohort. Family history of strabismus was not reported for 2 participants (3%) in glasses group in the Younger Cohort.	78 Participants n=244 Participants • Family history of strabismus was not available for 2 (3%) participants in glasses group and 1 (2%) in the observation group in the Older Cohort. Family history of strabismus was not reported for 2 participants (3%) in glasses group in the Younger Cohort.
Diagnosis Of ADHD	0 Participants n=61 Participants	0 Participants n=58 Participants	0 Participants n=65 Participants	0 Participants n=65 Participants	0 Participants n=249 Participants
SE Refractive Error: More hyperopic eye +2.00D to <+3.00D	0 Participants n=61 Participants	0 Participants n=58 Participants	0 Participants n=65 Participants	0 Participants n=65 Participants	0 Participants n=249 Participants
SE Refractive Error: More hyperopic eye +6.00 to +7.00 D	0 Participants n=61 Participants	0 Participants n=58 Participants	1 Participants n=65 Participants	5 Participants n=65 Participants	6 Participants n=249 Participants
SE Refractive Error: More hyperopic eye +3.00D to <+4.00D	37 Participants n=61 Participants	32 Participants n=58 Participants	25 Participants n=65 Participants	20 Participants n=65 Participants	114 Participants n=249 Participants
SE Refractive Error: More hyperopic eye +4.00D to <+5.00D	16 Participants n=61 Participants	19 Participants n=58 Participants	19 Participants n=65 Participants	27 Participants n=65 Participants	81 Participants n=249 Participants
SE Refractive Error: More hyperopic eye +5.00D to +6.00D	8 Participants n=61 Participants	7 Participants n=58 Participants	20 Participants n=65 Participants	13 Participants n=65 Participants	48 Participants n=249 Participants
SE Refractive Error: More hyperopic eye +1.00 to <+2.00 D	0 Participants n=61 Participants	0 Participants n=58 Participants	0 Participants n=65 Participants	0 Participants n=65 Participants	0 Participants n=249 Participants
SE Refractive Error: More hyperopic eye	3.93 diopters (D) STANDARD_DEVIATION 0.71 • n=61 Participants	3.94 diopters (D) STANDARD_DEVIATION 0.74 • n=58 Participants	4.32 diopters (D) STANDARD_DEVIATION 0.85 • n=65 Participants	4.37 diopters (D) STANDARD_DEVIATION 0.87 • n=65 Participants	4.15 diopters (D) STANDARD_DEVIATION 0.82 • n=249 Participants
SE Refractive Error: Less hyperopic eye +1.00 to <+2.00 D	0 Participants n=61 Participants	0 Participants n=58 Participants	0 Participants n=65 Participants	1 Participants n=65 Participants	1 Participants n=249 Participants
SE Refractive Error: Less hyperopic eye +2.00 to <+3.00D	10 Participants n=61 Participants	10 Participants n=58 Participants	4 Participants n=65 Participants	2 Participants n=65 Participants	26 Participants n=249 Participants
SE Refractive Error: Less hyperopic eye +3.00 to <+4.00D	34 Participants n=61 Participants	30 Participants n=58 Participants	26 Participants n=65 Participants	27 Participants n=65 Participants	117 Participants n=249 Participants
SE Refractive Error: Less hyperopic eye +4.00 to <+5.00D	12 Participants n=61 Participants	13 Participants n=58 Participants	22 Participants n=65 Participants	21 Participants n=65 Participants	68 Participants n=249 Participants
SE Refractive Error: Less hyperopic eye +5.00 to <+6.00D	5 Participants n=61 Participants	5 Participants n=58 Participants	13 Participants n=65 Participants	11 Participants n=65 Participants	34 Participants n=249 Participants
SE Refractive Error: Less hyperopic eye +6.00 to <+7.00D	0 Participants n=61 Participants	0 Participants n=58 Participants	0 Participants n=65 Participants	3 Participants n=65 Participants	3 Participants n=249 Participants
SE Refractive Error: Less hyperopic eye	3.60 diopters (D) STANDARD_DEVIATION 0.78 • n=61 Participants	3.59 diopters (D) STANDARD_DEVIATION 0.81 • n=58 Participants	4.04 diopters (D) STANDARD_DEVIATION 0.85 • n=65 Participants	4.07 diopters (D) STANDARD_DEVIATION 0.90 • n=65 Participants	3.84 diopters (D) STANDARD_DEVIATION 0.86 • n=249 Participants
Anisometropia 0.00 to <+0.50	42 Participants n=61 Participants	39 Participants n=58 Participants	47 Participants n=65 Participants	46 Participants n=65 Participants	174 Participants n=249 Participants
Anisometropia +0.50D to <+1.00D	16 Participants n=61 Participants	14 Participants n=58 Participants	13 Participants n=65 Participants	12 Participants n=65 Participants	55 Participants n=249 Participants
Anisometropia +1.00D to +1.50D	3 Participants n=61 Participants	5 Participants n=58 Participants	5 Participants n=65 Participants	7 Participants n=65 Participants	20 Participants n=249 Participants
Anisometropia	0.33 diopters (D) STANDARD_DEVIATION 0.36 • n=61 Participants	0.34 diopters (D) STANDARD_DEVIATION 0.34 • n=58 Participants	0.28 diopters (D) STANDARD_DEVIATION 0.38 • n=65 Participants	0.30 diopters (D) STANDARD_DEVIATION 0.39 • n=65 Participants	0.31 diopters (D) STANDARD_DEVIATION 0.37 • n=249 Participants
Astigmatism: More astigmatic eye 0.00D to <+0.50D	29 Participants n=61 Participants	29 Participants n=58 Participants	36 Participants n=65 Participants	29 Participants n=65 Participants	123 Participants n=249 Participants
Astigmatism: More astigmatic eye +0.50D to <+1.00D	23 Participants n=61 Participants	18 Participants n=58 Participants	18 Participants n=65 Participants	19 Participants n=65 Participants	78 Participants n=249 Participants
Astigmatism: More astigmatic eye +1.00D to +1.50D	9 Participants n=61 Participants	11 Participants n=58 Participants	11 Participants n=65 Participants	17 Participants n=65 Participants	48 Participants n=249 Participants
Astigmatism: More astigmatic eye	0.45 diopters (D) STANDARD_DEVIATION 0.45 • n=61 Participants	0.44 diopters (D) STANDARD_DEVIATION 0.44 • n=58 Participants	0.40 diopters (D) STANDARD_DEVIATION 0.48 • n=65 Participants	0.49 diopters (D) STANDARD_DEVIATION 0.48 • n=65 Participants	0.45 diopters (D) STANDARD_DEVIATION 0.46 • n=249 Participants
Astigmatism: Less astigmatic eye 0.00D to <+0.50D	40 Participants n=61 Participants	41 Participants n=58 Participants	41 Participants n=65 Participants	39 Participants n=65 Participants	161 Participants n=249 Participants
Astigmatism: Less astigmatic eye +0.50D to <+1.00D	14 Participants n=61 Participants	12 Participants n=58 Participants	17 Participants n=65 Participants	13 Participants n=65 Participants	56 Participants n=249 Participants
Astigmatism: Less astigmatic eye +1.00D to +1.50D	7 Participants n=61 Participants	5 Participants n=58 Participants	7 Participants n=65 Participants	13 Participants n=65 Participants	32 Participants n=249 Participants
Astigmatism: Less astigmatic eye	0.32 diopters (D) STANDARD_DEVIATION 0.42 • n=61 Participants	0.25 diopters (D) STANDARD_DEVIATION 0.36 • n=58 Participants	0.27 diopters (D) STANDARD_DEVIATION 0.38 • n=65 Participants	0.37 diopters (D) STANDARD_DEVIATION 0.47 • n=65 Participants	0.31 diopters (D) STANDARD_DEVIATION 0.41 • n=249 Participants
Distance Visual Acuity: Better-seeing Eye 20/16	5 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	3 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	8 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Distance Visual Acuity: Better-seeing Eye 20/20	16 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	18 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	34 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Distance Visual Acuity: Better-seeing Eye 20/25	25 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	18 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	43 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Distance Visual Acuity: Better-seeing Eye 20/32	9 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	13 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	22 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Distance Visual Acuity: Better-seeing Eye 20/40	6 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	6 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	12 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Distance Visual Acuity: Better-seeing Eye 20/50	0 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	0 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	0 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Distance Visual Acuity: Better-seeing Eye	0.09 logMAR STANDARD_DEVIATION 0.11 • n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	0.10 logMAR STANDARD_DEVIATION 0.11 • n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	0.10 logMAR STANDARD_DEVIATION 0.11 • n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Distance Visual Acuity: Worse-seeing Eye 20/16	2 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	0 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	2 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Distance Visual Acuity: Worse-seeing Eye 20/20	7 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	7 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	14 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Distance Visual Acuity: Worse-seeing Eye 20/25	26 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	25 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	51 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Distance Visual Acuity: Worse-seeing Eye 20/32	15 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	15 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	30 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Distance Visual Acuity: Worse-seeing Eye 20/40	8 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	9 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	17 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Distance Visual Acuity: Worse-seeing Eye 20/50	3 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	2 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	5 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Distance Visual Acuity: Worse-seeing Eye	0.15 logMAR STANDARD_DEVIATION 0.11 • n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	0.16 logMAR STANDARD_DEVIATION 0.10 • n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	0.15 logMAR STANDARD_DEVIATION 0.11 • n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Stereoacuity at Near 40	9 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	7 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	16 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Stereoacuity at Near 60	21 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	12 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	33 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Stereoacuity at Near 100	13 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	15 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	28 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Stereoacuity at Near 200	12 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	16 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	28 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Stereoacuity at Near 400	6 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	6 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	12 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Stereoacuity at Near Nil	0 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	1 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	1 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Stereoacuity at Near Failed pretest	0 Participants n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	1 Participants n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	1 Participants n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.
Stereoacuity at Near	100 seconds of arc (arcsec) n=61 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	100 seconds of arc (arcsec) n=58 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.	—	—	100 seconds of arc (arcsec) n=119 Participants • This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.

PRIMARY outcome

Timeframe: 36 months after randomization

Population: Overall number is the number of patients who completed the entire study.

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=41 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=43 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=53 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=53 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Number of Participants With Confirmation of Failure Criteria	5 Participants	4 Participants	11 Participants	18 Participants

SECONDARY outcome

Timeframe: 36 months after randomization

Population: Total number that experienced failure, as reported in primary outcome

Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=5 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=4 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=11 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=18 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Subgroup Analysis - Race Race - Non-white	2 Participants	1 Participants	0 Participants	4 Participants
Subgroup Analysis - Race Race - White	3 Participants	3 Participants	11 Participants	14 Participants

SECONDARY outcome

Timeframe: 36 months

Population: Total number that experienced failure, as reported in primary outcome

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=5 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=4 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=11 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=18 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Subgroup Analysis - Gender Gender- Female	4 Participants	3 Participants	4 Participants	10 Participants
Subgroup Analysis - Gender Gender - Male	1 Participants	1 Participants	7 Participants	8 Participants

SECONDARY outcome

Timeframe: 36 months

Population: Total number that experienced failure, as reported in primary outcome

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=5 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=4 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=11 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=18 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Subgroup Analysis - Family History of Amblyopia Family History of Amblyopia- Yes	3 Participants	0 Participants	4 Participants	6 Participants
Subgroup Analysis - Family History of Amblyopia Family History of Amblyopia- No	2 Participants	4 Participants	7 Participants	12 Participants

SECONDARY outcome

Timeframe: 36 months

Population: Total number that experienced failure, as reported in primary outcome

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=5 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=4 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=11 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=18 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Subgroup Analysis - Family History of Strabismus Family History of Strabismus- Yes	3 Participants	0 Participants	5 Participants	7 Participants
Subgroup Analysis - Family History of Strabismus Family History of Strabismus- No	2 Participants	4 Participants	6 Participants	11 Participants

SECONDARY outcome

Timeframe: 36 months

Population: Total number that experienced failure, as reported in primary outcome

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=5 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=4 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=11 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=18 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Subgroup Analysis - SE Anisometropia 0.00D to <+0.50D	3 Participants	4 Participants	8 Participants	14 Participants
Subgroup Analysis - SE Anisometropia +0.50D to <+1.00D	2 Participants	0 Participants	2 Participants	1 Participants
Subgroup Analysis - SE Anisometropia +1.00D to +1.50D	0 Participants	0 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 36 months

Population: Total number that experienced failure, as reported in primary outcome

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=5 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=4 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=11 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=18 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) +2.50D to <+4.00D	3 Participants	2 Participants	2 Participants	6 Participants
Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) +4.00D to <+5.00D	1 Participants	1 Participants	5 Participants	7 Participants
Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters) +5.00D to +6.00D	1 Participants	1 Participants	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Enrollment to <36 months

Estimate of Cumulative Deterioration Rate. Proportion of subjects who deteriorated during the course of the study were evaluated. Reasons for deterioration included stereoacuity, strabismus, treatment due to parental concern, and treatment that was prescribed against protocol.

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=61 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=58 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=65 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=65 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Deterioration Criteria Met (Prior to 3 Years)	16 Participants	14 Participants	20 Participants	36 Participants

SECONDARY outcome

Timeframe: Enrollment to 3 years

Population: Overall number is the total number of patients who completed the 3-year study.

Refractive error is the measurement of the power of the lenses needed to focus light on the retina. This is measured in diopters (D). Spherical Equivalent is a pair of numbers, one for each eye, that gives an estimate of the refractive error in the eyes. Hyperopia is farsightedness, or a type of refractive error in which things are seen more clearly at a distance than at near. Myopia is nearsightedness, or refractive error in which things are seen more clearly at near. Mean change in SE refractive error is from baseline to 3 years, measured in diopters. Negative values indicate a shift in the myopic direction.

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=41 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=43 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=53 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=53 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters) More Hyperopic Eye	-0.07 diopters Interval -0.33 to 0.19	-0.67 diopters Interval -0.92 to -0.41	0.15 diopters Interval -0.21 to 0.51	-0.01 diopters Interval -0.37 to 0.35
Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters) Less Hyperopic Eye	0 diopters Interval -0.26 to 0.26	-0.58 diopters Interval -0.84 to -0.33	0.30 diopters Interval -0.05 to 0.64	0.08 diopters Interval -0.27 to 0.42

SECONDARY outcome

Timeframe: Enrollment to 3 years

Population: Overall number is the number of patients that completed the 3-year study in the Older Cohort. This measure was not recorded for Younger Cohort.

Percentage of Participants (%) in which hyperopia reduced by 1.00D (diopters) or more over 3 years

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=41 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=43 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Percentage of Participants With Hyperopia Reduction More Hyperopic Eye	17 percentage of participants	42 percentage of participants	—	—
Percentage of Participants With Hyperopia Reduction Less Hyperopic Eye	20 percentage of participants	37 percentage of participants	—	—

SECONDARY outcome

Timeframe: 36 months after randomization

A treatment group comparison of the mean maximum visual acuity per subject at the masked 36-month visit (best visual acuity on any test with and without correction) will be performed using a t-test. Evaluated the best of the values reported with and without trial frames, during initial assessment and retest. Snellen visual acuity (VA) equivalents were converted to logarithm of minimum angle of resolution (logMAR) equivalents (in parentheses) as follows: 20/16 (-0.1), 20/20 (0), 20/25 (0.1), 20/32 (0.2), 20/40 (0.3), 20/50 (0.4) A logMAR value of less than 0 is associated with better than 20/20 vision, while a logMAR value greater than 0 is associated with worse than 20/20 vision.

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=41 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=43 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=53 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=53 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Best Visual Acuity Better-seeing Eye	-0.06 logMAR Standard Deviation 0.06	-0.07 logMAR Standard Deviation 0.05	0.06 logMAR Standard Deviation 0.12	0.12 logMAR Standard Deviation 0.13
Best Visual Acuity Worse-seeing Eye	-0.03 logMAR Standard Deviation 0.08	-0.01 logMAR Standard Deviation 0.10	0.16 logMAR Standard Deviation 0.23	0.23 logMAR Standard Deviation 0.26

SECONDARY outcome

Timeframe: 36 months

Population: Overall number is the total number of patients who completed the 3-year study.

Proportion who failed to meet age-normal VA at distance at 3 years. Participants were classified as failing to meet age-normal visual acuity if, for either eye, distance visual acuity was below age-normal values both with and without trial frames, during initial assessment and re-test.

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=41 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=43 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=53 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=53 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Failure to Meet Age-Normal VA at Distance	0 Participants	1 Participants	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 36 months after randomization

Population: Overall number is the total number of patients who completed the 3-year study.

A treatment group comparison of the proportion of subjects who developed amblyopia at distance during the course of the study will be performed using the Barnard's exact test. Participants were classified as having amblyopia if any of the following criteria were met: 1) the interocular difference was ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye, or 2) the interocular differences was ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye. 3) VA less than age normal in each eye (presumed bilateral amblyopia)

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=41 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=43 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=53 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=53 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Proportion With Amblyopia (at Distance)	0 Participants	1 Participants	7 Participants	9 Participants

SECONDARY outcome

Timeframe: 36 months after randomization

Population: Overall number is the total number of patients who completed the 3-year study.

A treatment group comparison of the mean binocular near visual acuity (logarithm of minimum angle of resolution, or logMAR) at the 36-month outcome exam will be performed. Assessment completed in randomized correction. Snellen visual acuity (VA) equivalents were converted to logarithm of minimum angle of resolution (logMAR) equivalents (in parentheses) as follows: 20/16 (-0.1), 20/20 (0), 20/25 (0.1), 20/32 (0.2), 20/40 (0.3), 20/50 (0.4) A logMAR value of less than 0 is associated with better than 20/20 vision, while a logMAR value greater than 0 is associated with worse than 20/20 vision.

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=41 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=43 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=53 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=53 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Binocular Near Visual Acuity	0.01 logMAR Standard Deviation 0.04	0.04 logMAR Standard Deviation 0.14	0.09 logMAR Standard Deviation 0.11	0.12 logMAR Standard Deviation 0.12

SECONDARY outcome

Timeframe: 36 months after randomization

Population: In the older cohort, one participant had esotropia. In the younger cohort, Three participants in the glasses group and two in the observation group received strabismus surgery prior to the 3-year visit. These participants are included in the table.

The number of participants who developed measurable heterotropia was estimated for each treatment group and the proportions were compared using Barnard's exact test.

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=41 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=43 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=53 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=53 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Number of Participants With Strabismus at 3 Years	0 Participants	1 Participants	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 36 months

Population: Overall number is the total number of patients who completed the 3-year study.

Mean stereoacuity at 3 years was measured in log seconds of arc (log arcsec) (see explanation below). Evaluated the best of the values reported with and without trial frames, during initial assessment and retest. Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec). Seconds of arc were converted to logarithm of seconds of arc, or log arcsec (in parentheses) as follows: 40 (1.60), 60(1.78), 100 (2.00), 200 (2.30), 400 (2.60), 800 (2.90), Nil (3.20)

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=41 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=43 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=53 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=53 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Mean Stereoacuity	1.76 logarithm of seconds of arc (log arcsec) Standard Deviation 0.20	1.75 logarithm of seconds of arc (log arcsec) Standard Deviation 0.23	2.2 logarithm of seconds of arc (log arcsec) Standard Deviation 0.52	2.3 logarithm of seconds of arc (log arcsec) Standard Deviation 0.55

SECONDARY outcome

Timeframe: 36 months

Population: Overall number is the total number of patients who completed the 3-year study.

Proportion who failed to meet age-normal stereoacuity. Participants were classified as failing to meet age-normal stereoacuity if near stereoacuity was below age-normal values both with and without trial frames, during initial assessment and re-test.

Outcome measures

Outcome measures
Measure	Glasses- Older Cohort n=41 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Older Cohort n=43 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Glasses- Younger Cohort n=53 Participants Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.	Observation- Younger Cohort n=53 Participants Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Glasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Failure to Meet Age-Normal Stereoacuity at 3 Years	5 Participants	3 Participants	6 Participants	16 Participants

Adverse Events

Glasses- Older Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Observation- Older Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Glasses- Younger Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Observation- Younger Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ray Kraker M.S.P.H.

Jaeb Center for Health Research

Phone: 813-975-8690

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place