Myopia-Night Blindness Clinical Trial
Official title:
Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality
| NCT number | NCT02965534 |
| Other study ID # | IGAMYO |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2015 |
| Est. completion date | March 2016 |
| Verified date | October 2018 |
| Source | University of Applied Sciences Jena |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | March 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Degle Optometry | Augsburg | Bavaria |
| Germany | University of Applied Sciences | Jena | TH |
| Germany | Hessler Optometry | Klingenberg am Main | Bavaria |
| Lead Sponsor | Collaborator |
|---|---|
| University of Applied Sciences Jena | IGA OPTIC EG |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. |
Baseline only | |
| 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. |
Baseline only | |
| 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) |
Test Period (4 weeks) | |
| 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) |
Test Period (4 weeks) | |
| 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) |
Test Period (4 weeks) | |
| 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) |
Test Period (4 weeks) |