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

Sponsor
Portsmouth Hospitals NHS Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT04061343
Collaborator
(none)
52
Enrollment
1
Location
12.3
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    52 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effects of chaNging LIGHT Levels on Contrast sENsitivity in Patients With Glaucoma
    Actual Study Start Date :
    Nov 20, 2018
    Anticipated Primary Completion Date :
    Nov 30, 2019
    Anticipated Study Completion Date :
    Nov 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. vision-related quality of life in patients with glaucoma [1 day study visit]

      assessed using the the visual functioning questionnaire - 25 questionnaire

    2. Visual function [through study completion, an average of 1 year]

      assessed using the low luminance questionnaire

    Secondary Outcome Measures

    1. 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)

    2. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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%)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Portsmouth Hospitals NHS Trust Portsmouth Hampshire United Kingdom PO6 3LY

    Sponsors and Collaborators

    • Portsmouth Hospitals NHS Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Portsmouth Hospitals NHS Trust
    ClinicalTrials.gov Identifier:
    NCT04061343
    Other Study ID Numbers:
    • PHT/2017/95
    First Posted:
    Aug 19, 2019
    Last Update Posted:
    Aug 19, 2019
    Last Verified:
    May 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glaucoma

    Study Results

    No Results Posted as of Aug 19, 2019