Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality
Primary Purpose
Myopia-Night Blindness
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Spectacle/Glasses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia-Night Blindness focused on measuring night vision, mesopic visual acuity, aberrometry, mesopic spectacle correction, night myopia
Eligibility Criteria
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
Sites / Locations
- Degle Optometry
- Hessler Optometry
- University of Applied Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Night Spectacle Correction
Spectacle Correction for photopic light conditions
Arm Description
Refraction for this glasses was obtained at low luminance.
Refraction for this glasses was obtained at high luminance level.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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)
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)
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)
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)
Full Information
NCT ID
NCT02965534
First Posted
November 14, 2016
Last Updated
October 16, 2018
Sponsor
University of Applied Sciences Jena
Collaborators
IGA OPTIC EG
1. Study Identification
Unique Protocol Identification Number
NCT02965534
Brief Title
Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality
Official Title
Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Applied Sciences Jena
Collaborators
IGA OPTIC EG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia-Night Blindness
Keywords
night vision, mesopic visual acuity, aberrometry, mesopic spectacle correction, night myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Night Spectacle Correction
Arm Type
Experimental
Arm Description
Refraction for this glasses was obtained at low luminance.
Arm Title
Spectacle Correction for photopic light conditions
Arm Type
Active Comparator
Arm Description
Refraction for this glasses was obtained at high luminance level.
Intervention Type
Device
Intervention Name(s)
Spectacle/Glasses
Primary Outcome Measure Information:
Title
Night Myopia
Description
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
Secondary Outcome Measure Information:
Title
Mesopic Visual Acuity Improvement
Description
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
Title
Subjective Vision Comfort in Dark Light Conditions
Description
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)
Title
Subjective Vision Sharpness in Dark Light Conditions
Description
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)
Title
Subjective Glare Sensitivity in Dark Light Conditions
Description
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)
Title
Subjective Driving Safety in Dark Light Conditions
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Degle, Prof.
Organizational Affiliation
University of Applied Sciences Jena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Degle Optometry
City
Augsburg
State/Province
Bavaria
Country
Germany
Facility Name
Hessler Optometry
City
Klingenberg am Main
State/Province
Bavaria
ZIP/Postal Code
63911
Country
Germany
Facility Name
University of Applied Sciences
City
Jena
State/Province
TH
ZIP/Postal Code
07745
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality
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