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

Not Applicable

Completed

Conditions: Myopia-Night Blindness

Interventions: Device: Spectacle/Glasses

Registration Number: NCT02965534

Lead Sponsor: University of Applied Sciences Jena

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Night Spectacle Correction	Spectacle/Glasses	Refraction for this glasses was obtained at low luminance.
Spectacle Correction for photopic light conditions	Spectacle/Glasses	Refraction for this glasses was obtained at high luminance level.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (3): Hessler Optometry
🇩🇪
Klingenberg am Main, Bavaria, Germany
University of Applied Sciences
🇩🇪
Jena, TH, Germany
Degle Optometry
🇩🇪
Augsburg, Bavaria, Germany