The Effects of Changing Light Levels on Contrast Sensitivity in Patients With Glaucoma

Completed

• Conditions: Glaucoma

• Registration Number: NCT04061343
• Lead Sponsor: Portsmouth Hospitals NHS Trust

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-11-20
• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-19
• Primary Completion: 2021-03-16
• Study Completion: 2021-03-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• • 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

Exclusion Criteria

• • 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%)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vision-related quality of life in patients with glaucoma	1 day study visit	assessed using the the visual functioning questionnaire - 25 questionnaire
Visual function	through study completion, an average of 1 year	assessed using the low luminance questionnaire

Secondary Outcome Measures

Name	Time	Method
To correlate visual impairment with contrast sensitivity results	through study completion, an average of 1 year	measured with Quality of Life questionnaires (Visual Functioning Questionnaire-25, Low Luminance Questionnaire)
Contrast Sensitivitiy	through study completion, an average of 1 year	Participants' contrast sensitivity will be tested under photopic (bright light conditions), mesopic (intermediate light conditions) and/or scotopic conditions (dim light conditions).

Trial Locations

Locations (1)

Portsmouth Hospitals NHS Trust; 🇬🇧 Portsmouth, Hampshire, United Kingdom