CClinicalTrials.gg
CompletedNCT04061343ENLIGHTENUpdated Apr 7, 2023

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

An observational study in Glaucoma, sponsored by Portsmouth Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-04-07.

Sponsored by Portsmouth Hospitals NHS Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
115
Ages
40 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Glaucoma

Browse trials for

03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 115 is above the median of 103 across 454 observational studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Portsmouth Hospitals NHS Trust is the lead sponsor of 74 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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%)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
115 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    assessed using the the visual functioning questionnaire - 25 questionnaire

    Time frame: 1 day study visit

  2. Visual function

    assessed using the low luminance questionnaire

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

Secondary outcomes

  1. To correlate visual impairment with contrast sensitivity results

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

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

  2. Contrast Sensitivitiy

    Participants' contrast sensitivity will be tested under photopic (bright light conditions), mesopic (intermediate light conditions) and/or scotopic conditions (dim light conditions).

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

07

Study locations

1 site
  • Portsmouth Hospitals NHS Trust
    Portsmouth, Hampshire PO6 3LY, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04061343
Lead sponsor
Portsmouth Hospitals NHS Trust
Responsible party
Sponsor
First posted
Aug 19, 2019
Start date
Nov 20, 2018
Primary completion
Mar 16, 2021
Completion
Mar 16, 2021
Last update
Apr 7, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion