GlaucomaENLIGHTENNCT04061343
The Effects of Changing Light Levels on Contrast Sensitivity in Patients With Glaucoma
An observational study of Glaucoma, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glaucoma
- How many people
- 115 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Nov 2018to 16 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- • 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
Who cannot join
- • 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%)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, PO6 3LY
About this study
Official title: 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.
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.
- Conditions
- Glaucoma
- Medical subject headings
- Glaucoma
What is being measured
The primary outcome is the main question the study is designed to answer.
vision-related quality of life in patients with glaucoma
assessed using the the visual functioning questionnaire - 25 questionnaire
Measured: 1 day study visit
Visual function
assessed using the low luminance questionnaire
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
To correlate visual impairment with contrast sensitivity results
measured with Quality of Life questionnaires (Visual Functioning Questionnaire-25, Low Luminance Questionnaire)
Measured: through study completion, an average of 1 year
Contrast Sensitivitiy
Participants' contrast sensitivity will be tested under photopic (bright light conditions), mesopic (intermediate light conditions) and/or scotopic conditions (dim light conditions).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start20 Nov 2018
- Primary completion16 Mar 2021
- Study completion16 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061343
- Sponsor's protocol ID
- PHT/2017/95
- Acronym
- ENLIGHTEN
- Status last verified
- Apr 2023
- First submitted
- 3 May 2019
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of chaNging LIGHT Levels on Contrast sENsitivity in Patients With Glaucoma
- ClinicalTrials.gov ID
- NCT04061343
- Acronym / sponsor ID
- ENLIGHTEN / PHT/2017/95
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- • Male or Female, aged 40 years or above.
Key exclusion criteria (8 listed)
- • Neovascular, uveitic, acute angle closure glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
vision-related quality of life in patients with glaucoma
Time frame: 1 day study visit
assessed using the the visual functioning questionnaire - 25 questionnaire
Visual function
Time frame: through study completion, an average of 1 year
assessed using the low luminance questionnaire
2 secondary outcomes
To correlate visual impairment with contrast sensitivity results
Time frame: through study completion, an average of 1 year
Contrast Sensitivitiy
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vision-related quality of life in patients with glaucoma (time frame: 1 day study visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.