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临床试验/NCT04061343
NCT04061343已完成不适用

The Effects of chaNging LIGHT Levels on Contrast sENsitivity in Patients With Glaucoma

Portsmouth Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2018年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
115
试验地点
1
主要终点
vision-related quality of life in patients with glaucoma

研究概览

简要总结

The study is a prospective observational study where participants will be recruited from the Ophthalmology department (Outpatient department, Eye Casualty). Only one research visit will be required. Participants will be asked to fill in a set of questionnaires (Visual Functioning Questionnaire-15(61), Low Luminance Questionnaire(62)) assessing their quality of life and vision and their full medical history will be collected. Then they will have their contrast sensitivity tested under various light conditions. If a recent visual field test is not available, that might be performed as part of the study.

详细描述

The purpose of our, real world study is to explore contrast sensitivity differences after changes in ambient light setting in patients with glaucoma compared with controls (patients with ocular hypertension). Participants will be asked to read a Pelli- Robson chart under photopic (bright light conditions) and mesopic (intermediate light conditions); followed by scotopic conditions (dim light conditions). This chart is a fast, easy, and effective way to measure spatial contrast sensitivity with reliable and reproducible results(60). This study will therefore help clinicians gain more insight into glaucoma related disability and provide a possible additional tool to visual field testing in patients with advanced glaucoma where VF testing may be hampered by floor effects.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Male or Female, aged 40 years or above.
  • Diagnosis of glaucoma (including primary open angle glaucoma, pigment dispersion syndrome, pseudoexfoliation, normal tension glaucoma, chronic angle closure glaucoma, narrow angle glaucoma) or ocular hypertension
  • Willing and able to give informed consent for participation in the study.
  • Best Corrected Visual Acuity equal or better than 6/12 as measured with the Snellen Chart

排除标准

  • • Neovascular, uveitic, acute angle closure glaucoma
  • Non-glaucomatous ocular disease such as AMD, Diabetic retinopathy, Inherited eye diseases
  • Visually significant cataracts (Distance VA ≤ 6/12 (0.30 LogMAR) and grade ≥ grade 2 nuclear sclerosis.)
  • Current use of miotic glaucoma medication
  • Incisional or laser eye surgery within 3 months of enrolment
  • Severely impaired cognition
  • Self-reported physical ability limiting function (e.g. stroke)
  • Unreliable visual fields (SITA Standard or SITA Fast: fixation losses >20% or false-positive errors >33% or false-negative errors >33%)

结局指标

主要结局

vision-related quality of life in patients with glaucoma

时间窗: 1 day study visit

assessed using the the visual functioning questionnaire - 25 questionnaire

Visual function

时间窗: through study completion, an average of 1 year

assessed using the low luminance questionnaire

次要结局

  • To correlate visual impairment with contrast sensitivity results(through study completion, an average of 1 year)
  • Contrast Sensitivitiy(through study completion, an average of 1 year)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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