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

NCT04061343 | Completed

• 1 other identifier: PHT/2017/95
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: August 19, 2019
• Study Start: November 20, 2018
• Primary Completion: March 16, 2021
• Study Completion: March 16, 2021
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

GB (1)