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Completed

NCT Number: NCT04061343

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Primary outcomes

  1. vision-related quality of life in patients with glaucoma

    Time frame: 1 day study visit

    assessed using the the visual functioning questionnaire - 25 questionnaire

  2. Visual function

    Time frame: through study completion, an average of 1 year

    assessed using the low luminance questionnaire

Secondary outcomes

  1. To correlate visual impairment with contrast sensitivity results

    Time frame: through study completion, an average of 1 year

    measured with Quality of Life questionnaires (Visual Functioning Questionnaire-25, Low Luminance Questionnaire)

  2. Contrast Sensitivitiy

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Registry information

Acronym: ENLIGHTEN

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2019
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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