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

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.

Study Overview

• Status: Completed
• Conditions: Myopia-Night Blindness
• Intervention / Treatment: Device: Spectacle/Glasses

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Augsburg, Bavaria, Germany
      • Degle Optometry
    • Klingenberg am Main, Bavaria, Germany, 63911
      • Hessler Optometry
  • TH
    • Jena, TH, Germany, 07745
      • University of applied sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Night Spectacle Correction; Refraction for this glasses was obtained at low luminance.	Device: Spectacle/Glasses
Active Comparator: Spectacle Correction for photopic light conditions; Refraction for this glasses was obtained at high luminance level.	Device: Spectacle/Glasses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline only

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline only
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)	Test Period (4 weeks)
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)	Test Period (4 weeks)
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)	Test Period (4 weeks)
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)	Test Period (4 weeks)

Collaborators and Investigators

• Sponsor: University of Applied Sciences Jena
• Collaborators: IGA OPTIC EG
• Investigators: Principal Investigator: Stephan Degle, Prof., University of Applied Sciences Jena

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: November 14, 2016
• First Posted (Estimate): November 16, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: night vision; mesopic visual acuity; aberrometry; mesopic spectacle correction; night myopia
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Sensation Disorders; Refractive Errors; Vision Disorders; Myopia; Night Blindness; Vitamin A Deficiency; Blindness
• Other Study ID Numbers: IGAMYO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No