Clinical trial NCT02965534: 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
Overall status: COMPLETED
Phase: NA
Conditions: Myopia-Night Blindness
Keywords: night vision
mesopic visual acuity
aberrometry
mesopic spectacle correction
night myopia
Lead sponsor: University of Applied Sciences Jena
Sponsor class: OTHER
Collaborators: name: IGA OPTIC EG
First posted: 2016-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Night Myopia
timeFrame: Baseline only
Secondary outcomes:
measure: Mesopic Visual Acuity Improvement
timeFrame: Baseline only
measure: Subjective Vision Comfort in Dark Light Conditions
timeFrame: Test Period (4 weeks)
measure: Subjective Vision Sharpness in Dark Light Conditions
timeFrame: Test Period (4 weeks)
measure: Subjective Glare Sensitivity in Dark Light Conditions
timeFrame: Test Period (4 weeks)
measure: Subjective Driving Safety in Dark Light Conditions
timeFrame: Test Period (4 weeks)
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Degle Optometry
state: Bavaria
city: Klingenberg am Main
country: Germany
facility: Hessler Optometry
state: Bavaria
city: Jena
country: Germany
facility: University of Applied Sciences
state: TH
Study officials:
affiliation: University of Applied Sciences Jena
name: Stephan Degle, Prof.
role: PRINCIPAL_INVESTIGATOR
References: