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

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma

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 Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

• Study Contact: Name: James Kirwan; Phone Number: 6263 02392286000; Email: james.kirwan@porthosp.nhs.uk
• Study Contact Backup: Name: Anastasios Sepetis; Phone Number: 6263 02392286000; Email: anastasiossepetis@nhs.net

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Portsmouth Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a 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 aged ≥40 years old.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Actual): March 16, 2021
• Study Completion (Actual): March 16, 2021

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: PHT/2017/95

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No