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

NCT ID: NCT02965534

Last Updated: 2019-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-03-31

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.

Conditions

Myopia-Night Blindness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Night Spectacle Correction

Refraction for this glasses was obtained at low luminance.

Group Type: EXPERIMENTAL

Spectacle/Glasses

Intervention Type: DEVICE

Spectacle Correction for photopic light conditions

Refraction for this glasses was obtained at high luminance level.

Group Type: ACTIVE_COMPARATOR

Spectacle/Glasses

Intervention Type: DEVICE

Interventions

Spectacle/Glasses

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IGA OPTIC EG

UNKNOWN

Sponsor Role: collaborator

University of Applied Sciences Jena

OTHER

Sponsor Role: lead

Responsible Party

Stephan Degle

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephan Degle, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Applied Sciences Jena

Locations

Degle Optometry

Augsburg, Bavaria, Germany

Hessler Optometry

Klingenberg am Main, Bavaria, Germany

University of Applied Sciences

Jena, Thuringia, Germany

Countries

Germany

Other Identifiers

IGAMYO

Identifier Type: -

Identifier Source: org_study_id