Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Night Myopia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Visual Acuity at least 0.8 (5/6)
- •Binocular Vision
排除标准
- •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
研究组 & 干预措施
Night Spectacle Correction
Refraction for this glasses was obtained at low luminance.
干预措施: Spectacle/Glasses (Device)
Spectacle Correction for photopic light conditions
Refraction for this glasses was obtained at high luminance level.
干预措施: Spectacle/Glasses (Device)
结局指标
主要结局
Night Myopia
时间窗: Baseline only
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.
次要结局
- Mesopic Visual Acuity Improvement(Baseline only)
- Subjective Vision Comfort in Dark Light Conditions(Test Period (4 weeks))
- Subjective Vision Sharpness in Dark Light Conditions(Test Period (4 weeks))
- Subjective Glare Sensitivity in Dark Light Conditions(Test Period (4 weeks))
- Subjective Driving Safety in Dark Light Conditions(Test Period (4 weeks))
研究者
Stephan Degle
Prof. Dr.
University of Applied Sciences Jena