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

University of Applied Sciences Jena

Status: Completed

Conditions: Myopia-Night Blindness

Treatments: Device: Spectacle/Glasses

Study type: Interventional

Funder types: Other

Identifiers

NCT02965534

IGAMYO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Night Spectacle Correction

Experimental group

Description:

Refraction for this glasses was obtained at low luminance.

Treatment:

Device: Spectacle/Glasses

Spectacle Correction for photopic light conditions

Active Comparator group

Description:

Refraction for this glasses was obtained at high luminance level.

Treatment:

Device: Spectacle/Glasses