Myopia-Night Blindness
Conditions
Keywords
night vision, mesopic visual acuity, aberrometry, mesopic spectacle correction, night myopia
Brief summary
Reduced quality of vision and glare in twilight or night are frequently mentioned complaints within the optometric examination. A reason for these problems could be a myopic refractive shift in dark light conditions, commonly known as night myopia or twilight myopia. The aim of this study was to investigate whether quality of vision in twilight or night could be improved by a spectacle correction optimized for mesopic light conditions. Moreover, objective refraction in large pupils measured by aberrometry was compared to subjective mesopic refraction.
Detailed description
After obtaining informed consent, aberrometry was performed in a darkened room (0.1 lux). Subjective photopic refraction and visual acuity were measured before light was turned off and mesopic refraction was obtained after a dark adaptation period of five minutes. Finally, frames and lenses were fitted by a centration system. Lens grinding was executed centralized by a grinding workshop. In the course of this study, subjects were randomly assigned to wear two glasses double-masked in turn. One with photopic subjective refraction data and another with mesopic subjective refraction data. Both were worn for 14 ± 2 days each. Follow Up 1: After two weeks, participants were asked for their subjective experiences with the first correction by a visual analogue scale questionnaire. After the evaluation, glasses were changed. Follow Up 2: Two weeks later, subjective experiences were evaluated again. After visual analogue scale questionnaire, subjects were asked to compare the two glasses concerning quality of mesopic vision and subjective safety level during night driving.
Interventions
DEVICESpectacle/Glasses
Sponsors
IGA OPTIC EG
University of Applied Sciences Jena
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Visual Acuity at least 0.8 (5/6) * Binocular Vision
Exclusion criteria
* refraction more than sph +/- 6 D and cyl 2 D * Difference between habitual correction and actual refraction more than 0.5 D * Medication with an influence on visual system * Disease or eye disease with an effect on the visual system * pregnancy or other hormonal variances * influence of drugs * mental handicap
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Night Myopia | Baseline only | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mesopic Visual Acuity Improvement | 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. |
| Subjective Vision Comfort in Dark Light Conditions | 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) |
| Subjective Vision Sharpness in Dark Light Conditions | 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) |
| Subjective Glare Sensitivity in Dark Light Conditions | 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) |
| Subjective Driving Safety in Dark Light Conditions | 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) |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects were included in Baseline and all investigations were obtained at these 100 subjects | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Aberrometry SE at small pupil OS | -1.36 D STANDARD_DEVIATION 1.86 |
| Aberrometry Spherical Equivalent (SE) large pupil OD | -1.67 D STANDARD_DEVIATION 1.68 |
| Aberrometry Spherical Equivalent (SE) large pupil OS | -1.58 D STANDARD_DEVIATION 1.83 |
| Aberrometry Spherical Equivalent (SE) small pupil OD | -1.44 D STANDARD_DEVIATION 1.74 |
| Age, Continuous | 27 years STANDARD_DEVIATION 6 |
| Binocular photopic Visual Acuity | -0.2 logMAR Visual Acuity |
| J0 Aberrometry OD large pupil | -0.02 D STANDARD_DEVIATION 0.31 |
| J0 Aberrometry OD small pupil | -0.03 D STANDARD_DEVIATION 0.26 |
| J0 Aberrometry OS large pupil | 0.03 D STANDARD_DEVIATION 0.31 |
| J0 Aberrometry OS small pupil | 0.01 D STANDARD_DEVIATION 0.29 |
| J0 Subjective Mesopic Refraction OD | -0.01 D STANDARD_DEVIATION 0.25 |
| J0 Subjective Mesopic Refraction OS | 0.03 D STANDARD_DEVIATION 0.27 |
| J0 Subjective Photopic Refraction OD | -0.01 D STANDARD_DEVIATION 0.26 |
| J0 Subjective Photopic Refraction OS | 0.03 D STANDARD_DEVIATION 0.23 |
| J45 Aberrometry OD large pupil | 0.01 D STANDARD_DEVIATION 0.31 |
| J45 Aberrometry OD small pupil | 0.01 D STANDARD_DEVIATION 0.35 |
| J45 Aberrometry OS large pupil | 0.01 D STANDARD_DEVIATION 0.3 |
| J45 Aberrometry OS small pupil | 0.01 D STANDARD_DEVIATION 0.3 |
| J45 Subjective Mesopic Refraction OD | -0.02 D STANDARD_DEVIATION 0.25 |
| J45 Subjective Mesopic Refraction OS | -0.01 D STANDARD_DEVIATION 0.22 |
| J45 Subjective Photopic Refraction OD | 0.01 D STANDARD_DEVIATION 0.21 |
| J45 Subjective Photopic Refraction OS | 0.05 D STANDARD_DEVIATION 0.23 |
| Max. pupil size aberrometry OD | 5.6 mm STANDARD_DEVIATION 0.7 |
| Max. pupil size aberrometry OS | 5.8 mm STANDARD_DEVIATION 0.8 |
| Mesopic Visual Acuity with Mesopic Refraction Binocular | 0.0 logMAR Visual Acuity |
| Mesopic Visual Acuity with Mesopic Refraction OD | 0.0 logMAR Visual Acuity |
| Mesopic Visual Acuity with Mesopic Refraction OS | 0.0 logMAR Visual Acuity |
| Mesopic Visual Acuity with photopic refraction Binocular | 0.1 logMAR Visual Acuity |
| Mesopic Visual Acuity with photopic refraction OD | 0.1 logMAR Visual Acuity |
| Mesopic Visual Acuity with photopic refraction OS | 0.1 logMAR Visual Acuity |
| Photopic Visual Acuity OD | -0.1 logMAR Visual Acuity |
| Photopic Visual Acuity OS | -0.1 logMAR Visual Acuity |
| Pupil size in mesopic light conditions OD | 6.5 mm STANDARD_DEVIATION 1.4 |
| Pupil size in mesopic light conditions OS | 6.6 mm STANDARD_DEVIATION 1.4 |
| Pupil size in photopic light conditions OD | 4.3 mm STANDARD_DEVIATION 1 |
| Pupil size in photopic light conditions OS | 4.3 mm STANDARD_DEVIATION 1 |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 22 Participants |
| Spherical Aberration OD | 0.100 µm STANDARD_DEVIATION 0.15 |
| Spherical Aberration OS | 0.093 µm STANDARD_DEVIATION 0.14 |
| Subjective Mesopic Refraction SE OD | -1.42 D STANDARD_DEVIATION 1.69 |
| Subjective Mesopic Refraction SE OS | -1.37 D STANDARD_DEVIATION 1.76 |
| Subjective photopic Refraction SE OD | -1.10 D STANDARD_DEVIATION 1.69 |
| Subjective photopic Refraction SE OS | -1.03 D STANDARD_DEVIATION 1.79 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Night Myopia
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.
Time frame: Baseline only
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Subjects | Night Myopia | Right Eye (OD): shift in SE | -0.30 D | Standard Deviation 0.2 |
| All Subjects | Night Myopia | Left Eye (OS): shift in SE | -0.32 D | Standard Deviation 0.21 |
Secondary
Mesopic Visual Acuity Improvement
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.
Time frame: Baseline only
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Subjects | Mesopic Visual Acuity Improvement | Right Eye (OD): visual acuity improvement | 0.1 logMAR visual acuity |
| All Subjects | Mesopic Visual Acuity Improvement | Left Eye (OS): visual acuity improvement | 0.1 logMAR visual acuity |
| All Subjects | Mesopic Visual Acuity Improvement | Binocular visual acuity improvement | 0.1 logMAR visual acuity |
Secondary
Subjective Driving Safety in Dark Light Conditions
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)
Time frame: Test Period (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Subjective Driving Safety in Dark Light Conditions | 57 scores on a scale (0 to 100) | Standard Deviation 32 |
| Spectacle Correction for Photopic Light Conditions | Subjective Driving Safety in Dark Light Conditions | 73 scores on a scale (0 to 100) | Standard Deviation 25 |
Secondary
Subjective Glare Sensitivity in Dark Light Conditions
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)
Time frame: Test Period (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Subjective Glare Sensitivity in Dark Light Conditions | 48 scores on a scale (0 to 100) | Standard Deviation 32 |
| Spectacle Correction for Photopic Light Conditions | Subjective Glare Sensitivity in Dark Light Conditions | 37 scores on a scale (0 to 100) | Standard Deviation 31 |
Secondary
Subjective Vision Comfort in Dark Light Conditions
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)
Time frame: Test Period (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Subjective Vision Comfort in Dark Light Conditions | 60 scores on a scale (0 to 100) | Standard Deviation 31 |
| Spectacle Correction for Photopic Light Conditions | Subjective Vision Comfort in Dark Light Conditions | 73 scores on a scale (0 to 100) | Standard Deviation 26 |
Secondary
Subjective Vision Sharpness in Dark Light Conditions
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)
Time frame: Test Period (4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Subjective Vision Sharpness in Dark Light Conditions | 59 evaluation points (0 to 100) | Standard Deviation 30 |
| Spectacle Correction for Photopic Light Conditions | Subjective Vision Sharpness in Dark Light Conditions | 73 evaluation points (0 to 100) | Standard Deviation 27 |