Trial Outcomes & Findings for Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality (NCT NCT02965534)

Last Updated: 2019-02-28

Results Overview

Value of refractive shift (SE) when changing luminance from a photopic to a mesopic level. At Baseline, participants were not separated into arms as the Randomization Process was carried out at a later time point after participants picked up study glasses. Therefore, data are presented for All Participants in one Arm/Group.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

Baseline only

Results posted on

2019-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Night Spectacle Correction - Photopic Spectacle Correction This arm has tested first the mesopic spectacle correction for 2 weeks and after this time the ("standard") photopic spectacle correction for two weeks Cross Over Design!	Photopic Spectacle Correction - Night Spectacle Correction This arm has tested first the standard photopic spectacle correction for two weeks and after this time the mesopic spectacle correction for two weeks Cross Over Design!
Overall Study STARTED	45	55
Overall Study COMPLETED	45	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=100 Participants All subjects were included in Baseline and all investigations were obtained at these 100 subjects
Age, Continuous	27 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Aberrometry Spherical Equivalent (SE) small pupil OD	-1.44 D STANDARD_DEVIATION 1.74 • n=5 Participants
Aberrometry SE at small pupil OS	-1.36 D STANDARD_DEVIATION 1.86 • n=5 Participants
Subjective photopic Refraction SE OD	-1.10 D STANDARD_DEVIATION 1.69 • n=5 Participants
Subjective photopic Refraction SE OS	-1.03 D STANDARD_DEVIATION 1.79 • n=5 Participants
Photopic Visual Acuity OD	-0.1 logMAR Visual Acuity n=5 Participants
Photopic Visual Acuity OS	-0.1 logMAR Visual Acuity n=5 Participants
Binocular photopic Visual Acuity	-0.2 logMAR Visual Acuity n=5 Participants
Mesopic Visual Acuity with photopic refraction OD	0.1 logMAR Visual Acuity n=5 Participants
Mesopic Visual Acuity with photopic refraction OS	0.1 logMAR Visual Acuity n=5 Participants
Mesopic Visual Acuity with photopic refraction Binocular	0.1 logMAR Visual Acuity n=5 Participants
Subjective Mesopic Refraction SE OD	-1.42 D STANDARD_DEVIATION 1.69 • n=5 Participants
Subjective Mesopic Refraction SE OS	-1.37 D STANDARD_DEVIATION 1.76 • n=5 Participants
Mesopic Visual Acuity with Mesopic Refraction OD	0.0 logMAR Visual Acuity n=5 Participants
Mesopic Visual Acuity with Mesopic Refraction OS	0.0 logMAR Visual Acuity n=5 Participants
Mesopic Visual Acuity with Mesopic Refraction Binocular	0.0 logMAR Visual Acuity n=5 Participants
Spherical Aberration OD	0.100 µm STANDARD_DEVIATION 0.15 • n=5 Participants
Spherical Aberration OS	0.093 µm STANDARD_DEVIATION 0.14 • n=5 Participants
Max. pupil size aberrometry OD	5.6 mm STANDARD_DEVIATION 0.7 • n=5 Participants
Max. pupil size aberrometry OS	5.8 mm STANDARD_DEVIATION 0.8 • n=5 Participants
Aberrometry Spherical Equivalent (SE) large pupil OD	-1.67 D STANDARD_DEVIATION 1.68 • n=5 Participants
Aberrometry Spherical Equivalent (SE) large pupil OS	-1.58 D STANDARD_DEVIATION 1.83 • n=5 Participants
Pupil size in photopic light conditions OD	4.3 mm STANDARD_DEVIATION 1.0 • n=5 Participants
Pupil size in photopic light conditions OS	4.3 mm STANDARD_DEVIATION 1.0 • n=5 Participants
Pupil size in mesopic light conditions OD	6.5 mm STANDARD_DEVIATION 1.4 • n=5 Participants
Pupil size in mesopic light conditions OS	6.6 mm STANDARD_DEVIATION 1.4 • n=5 Participants
J0 Aberrometry OD small pupil	-0.03 D STANDARD_DEVIATION 0.26 • n=5 Participants
J0 Aberrometry OS small pupil	0.01 D STANDARD_DEVIATION 0.29 • n=5 Participants
J45 Aberrometry OD small pupil	0.01 D STANDARD_DEVIATION 0.35 • n=5 Participants
J45 Aberrometry OS small pupil	0.01 D STANDARD_DEVIATION 0.30 • n=5 Participants
J0 Aberrometry OD large pupil	-0.02 D STANDARD_DEVIATION 0.31 • n=5 Participants
J0 Aberrometry OS large pupil	0.03 D STANDARD_DEVIATION 0.31 • n=5 Participants
J45 Aberrometry OD large pupil	0.01 D STANDARD_DEVIATION 0.31 • n=5 Participants
J45 Aberrometry OS large pupil	0.01 D STANDARD_DEVIATION 0.30 • n=5 Participants
J0 Subjective Photopic Refraction OD	-0.01 D STANDARD_DEVIATION 0.26 • n=5 Participants
J0 Subjective Photopic Refraction OS	0.03 D STANDARD_DEVIATION 0.23 • n=5 Participants
J45 Subjective Photopic Refraction OD	0.01 D STANDARD_DEVIATION 0.21 • n=5 Participants
J45 Subjective Photopic Refraction OS	0.05 D STANDARD_DEVIATION 0.23 • n=5 Participants
J0 Subjective Mesopic Refraction OD	-0.01 D STANDARD_DEVIATION 0.25 • n=5 Participants
J0 Subjective Mesopic Refraction OS	0.03 D STANDARD_DEVIATION 0.27 • n=5 Participants
J45 Subjective Mesopic Refraction OD	-0.02 D STANDARD_DEVIATION 0.25 • n=5 Participants
J45 Subjective Mesopic Refraction OS	-0.01 D STANDARD_DEVIATION 0.22 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline only

Outcome measures

Outcome measures
Measure	All Subjects n=100 Participants	Spectacle Correction for Photopic Light Conditions Refraction for this glasses was obtained at high luminance level. Spectacle/Glasses
Night Myopia Right Eye (OD): shift in SE	-0.30 D Standard Deviation 0.2	—
Night Myopia Left Eye (OS): shift in SE	-0.32 D Standard Deviation 0.21	—

SECONDARY outcome

Timeframe: Baseline only

Difference of visual acuity (monocular and binocular) in a darkened room (0.1 lux) after a dark adaption period of 5 min. with photopic spectacle correction ("classic" refraction obtained in photopic light conditions) compared to mesopic spectacle correction (correction of night myopia) Scale: logMAR visual acuity, using Landolt C optotypes. At Baseline, participants were not separated into arms as the Randomization Process was carried out at a later time point after participants picked up study glasses. Therefore, data are presented for All Participants in one Arm/Group.

Outcome measures

Outcome measures
Measure	All Subjects n=100 Participants	Spectacle Correction for Photopic Light Conditions Refraction for this glasses was obtained at high luminance level. Spectacle/Glasses
Mesopic Visual Acuity Improvement Right Eye (OD): visual acuity improvement	0.1 logMAR visual acuity Interval 0.0 to 0.4	—
Mesopic Visual Acuity Improvement Left Eye (OS): visual acuity improvement	0.1 logMAR visual acuity Interval 0.0 to 0.3	—
Mesopic Visual Acuity Improvement Binocular visual acuity improvement	0.1 logMAR visual acuity Interval 0.0 to 0.3	—

SECONDARY outcome

Timeframe: Test Period (4 weeks)

Evaluation of subjective perceived vision comfort with the study and control glasses. Both glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used. Question: How would you evaluate vision comfort with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (insufficient) to 100 (very good)

Outcome measures

Outcome measures
Measure	All Subjects n=100 Participants	Spectacle Correction for Photopic Light Conditions n=100 Participants Refraction for this glasses was obtained at high luminance level. Spectacle/Glasses
Subjective Vision Comfort in Dark Light Conditions	60 scores on a scale (0 to 100) Standard Deviation 31	73 scores on a scale (0 to 100) Standard Deviation 26

SECONDARY outcome

Timeframe: Test Period (4 weeks)

Evaluation of subjective perceived vision sharpness with the study and control glasses. Both glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used. Question: How would you evaluate vision sharpness with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (insufficient) to 100 (very good)

Outcome measures

Outcome measures
Measure	All Subjects n=100 Participants	Spectacle Correction for Photopic Light Conditions n=100 Participants Refraction for this glasses was obtained at high luminance level. Spectacle/Glasses
Subjective Vision Sharpness in Dark Light Conditions	59 evaluation points (0 to 100) Standard Deviation 30	73 evaluation points (0 to 100) Standard Deviation 27

SECONDARY outcome

Timeframe: Test Period (4 weeks)

Evaluation of subjective perceived glare sensitivity with the study and control glasses. Both glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used. Question: How would you evaluate glare sensitivity with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (no glare) to 100 (strong glare)

Outcome measures

Outcome measures
Measure	All Subjects n=100 Participants	Spectacle Correction for Photopic Light Conditions n=100 Participants Refraction for this glasses was obtained at high luminance level. Spectacle/Glasses
Subjective Glare Sensitivity in Dark Light Conditions	48 scores on a scale (0 to 100) Standard Deviation 32	37 scores on a scale (0 to 100) Standard Deviation 31

SECONDARY outcome

Timeframe: Test Period (4 weeks)

Evaluation of subjective perceived driving safety sense with the study and control glasses. Both glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used. Question: How would you evaluate driving safety sense when driving in twilight or night with the tested glasses? Answer: visual analogue scale slider from 0 (not safe) to 100 (very safe)

Outcome measures

Outcome measures
Measure	All Subjects n=100 Participants	Spectacle Correction for Photopic Light Conditions n=100 Participants Refraction for this glasses was obtained at high luminance level. Spectacle/Glasses
Subjective Driving Safety in Dark Light Conditions	57 scores on a scale (0 to 100) Standard Deviation 32	73 scores on a scale (0 to 100) Standard Deviation 25

Adverse Events

Night Spectacle Correction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Spectacle Correction for Photopic Light Conditions

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

Philipp Hessler

University of Applied Sciences Jena

Phone: +4916097089677

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place