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

Glaucoma Clinical Trial

— ENLIGHTEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04061343
• Other study ID #: PHT/2017/95
• Status: Completed
• Start date: November 20, 2018
• Est. completion date: March 16, 2021

Study information

• Verified date: April 2023
• Source: Portsmouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: March 16, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Glaucoma

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals NHS Trust	Portsmouth	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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