Retinitis PigmentosaCLIRPNCT06224114
Coloured-light in Retinitis Pigmentosa.
A study testing Coloured-light torch and Different coloured-light torch in people with Retinitis Pigmentosa, run by University College, London at 1 site in United Kingdom.
Trial summary
This study will assess the effect of 2 different colours of light on colour vision in adults with retinitis pigments (RP). Participants will be 18 years or above with a genetically confirmed molecular diagnosis of RP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- Coloured-light torch and Different coloured-light torch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2024to Oct 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Typical RP where the underlying genetic cause is known. This may include PRPF31, PRPF8, SNRNP200, RHO, RP1 [autosomal dominant] and USH2A, EYS [autosomal recessive]
- VA of 0.30 LogMAR (6/12) or better in the study eye
- Preserved foveal structure defined by intact outer retinal (ellipsoid zone) at the fovea on Optical Coherence Tomography (OCT) and a hyperfluorescent ring within the temporal vascular arcades on Fundus Autofluorescence (FAF) in the study eye
- Willing and able to provide written informed consent
Who cannot join
- Co-existing ocular pathology will be excluded; however, participants with macular oedema, a common pre-symptomatic manifestation of foveal involvement, will not be excluded
- Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within 6 months of study enrolment
- Unwilling or able to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust
London
Hannah Dunbar, PhD
About this study
Official title: A Pilot, Randomised, Masked Study to Investigate the Effect of Coloured-light on Colour Contrast Thresholds in Retinitis Pigmentosa.
This study will assess the effect of 2 different colours of light on colour vision in adults with retinitis pigments (RP). Participants will be 18 years or above with a genetically confirmed molecular diagnosis of RP. After informed consent, participants will have their letter chart vision and colour vision measured in their study eye. They will then be they will be randomly allocated to one of 2 groups. The study team will not know which group they have been assigned to. Group 1 will be given a coloured-light hand-held torch and be asked to apply it to their study eye for 3 minutes at home each morning between 8 - 10 am for 28 days. Group 2 will be given a different colour hand-held torch and be asked to do the same. All participants will have their letter chart vision and colour vision measured at the end of study on day 28 (+ 7 days).
Read the detailed description
This is a pilot, randomised, masked, single-site trial designed to assess the effect of coloured light exposure on cone contrast thresholds (CCT) in adults with RP.
70 adults with typical RP in which the underlying genetic cause is known will be recruited from Moorfields Eye Hospital genetics service.
Following informed consent, participants will be invited for a baseline study visit.
At a baseline visit, prior to any light exposure (day 0), participants will undergo Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity (VA) and CCT measurements performed by an experienced technician according to dedicated standard operating procedures. The order of testing will be as follows:
- Study eye: LogMAR VA
- Study eye: CCT (Tritan and Protan)
After baseline assessments have been completed, participants will be randomised to the intervention (n=35) or control group (n=35) by a study nurse. All other study team members will be masked to group allocation.
The intervention group will be provided with a coloured torch and instructed to apply it to their study eye for 3 minutes at home each morning between 8 - 10 am for 28 days. The control group will be provided with a different coloured torch and will be instructed to follow the same protocol. The specific colours have not be disclosed here to protect masking of the study. Participants will be asked to complete a paper diary each day to record whether light was applied, the time and duration of the application and the eye to which light was applied.
The end of trial visit will be scheduled on day 28 (+7 days). Participants will undergo LogMAR VA and CCT measurements by an experienced technician according to standard operating procedures (SOP). The order of testing will be as follows:
- Study eye: LogMAR VA
- Study eye: CCT (Tritan and Protan)
- Conditions
- Retinitis Pigmentosa
- Being tested
- Coloured-light torch, Different coloured-light torch
- Keywords
- Inherited eye disease, Retinal dystrophy, Retinitis Pigmentosa, Visual impairment, Photobiomodulation, Mitochondrial Dysfunction
- Medical subject headings
- Retinitis Pigmentosa, Retinal Dystrophies, Vision Disorders, Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloured-light torchDevice
Participant administered, at-home, 3-minute daily morning application (between 8 - 10am) of a coloured-light torch to the study eye.
Different coloured-light torchDevice
Participant administered, at-home, 3-minute daily morning application (between 8 - 10am) of a different coloured-light torch to the study eye.
| Study group | Role | What they receive |
|---|---|---|
| Coloured light 1 group | Experimental | Coloured light 1 group will be provided with a coloured-light torch and instructed to apply it to their study eye for 3 minutes at home each morning between 8 - 10 am for 28 days. Receives: Device: Coloured-light torch |
| Coloured light 2 group | Placebo comparator | Coloured light 2 group will be provided with a different coloured-light torch and instructed to apply it to their study eye for 3 minutes at home each morning between 8 - 10 am for 28 days. Receives: Device: Different coloured-light torch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tritan Colour Contrast Threshold (CCT)
Tritan CCT will be measured using the ChromaTest® platform, a software program which quantifies age-corrected tritan and protan CCT using a Modified Binary Search method. Tritan CCT test endpoint is a continuous variable (units: percentage).
Measured: Measured at Day 0 and Day 28
Secondary outcomes (4)
Protan CCT
Protan CCT will be measured using the ChromaTest® platform, a software program which quantifies age-corrected tritan and protan CCT using a Modified Binary Search method. Protan CCT test endpoint is a continuous variable (units: percentage).
Measured: Measured at Day 0 and Day 28
LogMAR Visual Acuity (LogMAR VA)
LogMAR VA will be measured on an electronic LogMAR acuity chart (Test Chart 2020, Thompson Software Solutions, UK), according to a forced-choice procedure.
Measured: Measured at Day 0 and Day 28
Proportion of participants losing ≥15 letters of LogMAR VA
Proportion of participants losing 15 letters of LogMAR VA or more at day 28 will be reported as a safety outcome.
Measured: Measured each day (Day 0 through Day 28)
Compliance rate
Compliance rate of application of daily, 3-minute, at-home, participant administered coloured-light exposure is a secondary endpoint. This will be collected through completion of a participant diary.
Measured: Measured each day (Day 0 through Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study startMar 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hannah Dunbar, PhD, Principal investigator, UCL Institute of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224114
- Sponsor's protocol ID
- 161090
- Acronym
- CLIRP
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Randomised, Masked Study to Investigate the Effect of Coloured-light on Colour Contrast Thresholds in Retinitis Pigmentosa.
- ClinicalTrials.gov ID
- NCT06224114
- Acronym / sponsor ID
- CLIRP / 161090
- Conditions
- Retinitis Pigmentosa
- Keywords
- Inherited eye disease, Retinal dystrophy, Retinitis Pigmentosa, Visual impairment, Photobiomodulation, Mitochondrial Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 25 Jan 2024 (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.
This study will assess the effect of 2 different colours of light on colour vision in adults with retinitis pigments (RP). Participants will be 18 years or above with a genetically confirmed molecular diagnosis of RP. After informed consent, participants will have their letter chart vision and colour vision measured in their study eye. They will then be they will be randomly allocated to one of 2 groups. The study team will not know which group they have been assigned to. Group 1 will be given a coloured-light hand-held torch and be asked to apply it to their study eye for 3 minutes at home each morning between 8 - 10 am for 28 days. Group 2 will be given a different colour hand-held torch and be asked to do the same. All participants will have their letter chart vision and colour vision measured at the end of study on day 28 (+ 7 days).
Detailed description
This is a pilot, randomised, masked, single-site trial designed to assess the effect of coloured light exposure on cone contrast thresholds (CCT) in adults with RP.
70 adults with typical RP in which the underlying genetic cause is known will be recruited from Moorfields Eye Hospital genetics service.
Following informed consent, participants will be invited for a baseline study visit.
At a baseline visit, prior to any light exposure (day 0), participants will undergo Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity (VA) and CCT measurements performed by an experienced technician according to dedicated standard operating procedures. The order of testing will be as follows:
- Study eye: LogMAR VA
- Study eye: CCT (Tritan and Protan)
After baseline assessments have been completed, participants will be randomised to the intervention (n=35) or control group (n=35) by a study nurse. All other study team members will be masked to group allocation.
The intervention group will be provided with a coloured torch and instructed to apply it to their study eye for 3 minutes at home each morning between 8 - 10 am for 28 days. The control group will be provided with a different coloured torch and will be instructed to follow the same protocol. The specific colours have not be disclosed here to protect masking of the study. Participants will be asked to complete a paper diary each day to record whether light was applied, the time and duration of the application and the eye to which light was applied.
The end of trial visit will be scheduled on day 28 (+7 days). Participants will undergo LogMAR VA and CCT measurements by an experienced technician according to standard operating procedures (SOP). The order of testing will be as follows:
- Study eye: LogMAR VA
- Study eye: CCT (Tritan and Protan)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coloured light 1 group | Experimental | Device: Coloured-light torchColoured light 1 group will be provided with a coloured-light torch and instructed to apply it to their study eye for 3 minutes at home each morning between 8 - 10 am for 28 days. |
| Coloured light 2 group | Placebo comparator | Device: Different coloured-light torchColoured light 2 group will be provided with a different coloured-light torch and instructed to apply it to their study eye for 3 minutes at home each morning between 8 - 10 am for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years old
- Typical RP where the underlying genetic cause is known. This may include PRPF31, PRPF8, SNRNP200, RHO, RP1 [autosomal dominant] and USH2A, EYS [autosomal recessive]
- VA of 0.30 LogMAR (6/12) or better in the study eye
- Preserved foveal structure defined by intact outer retinal (ellipsoid zone) at the fovea on Optical Coherence Tomography (OCT) and a hyperfluorescent ring within the temporal vascular arcades on Fundus Autofluorescence (FAF) in the study eye
- Willing and able to provide written informed consent
Key exclusion criteria (3 listed)
- Co-existing ocular pathology will be excluded; however, participants with macular oedema, a common pre-symptomatic manifestation of foveal involvement, will not be excluded
- Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within 6 months of study enrolment
- Unwilling or able to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coloured-light torchParticipant administered, at-home, 3-minute daily morning application (between 8 - 10am) of a coloured-light torch to the study eye. | Device | Coloured light 1 group |
| Different coloured-light torchParticipant administered, at-home, 3-minute daily morning application (between 8 - 10am) of a different coloured-light torch to the study eye. | Device | Coloured light 2 group |
Primary outcome
Tritan Colour Contrast Threshold (CCT)
Time frame: Measured at Day 0 and Day 28
Tritan CCT will be measured using the ChromaTest® platform, a software program which quantifies age-corrected tritan and protan CCT using a Modified Binary Search method. Tritan CCT test endpoint is a continuous variable (units: percentage).
4 secondary outcomes
Protan CCT
Time frame: Measured at Day 0 and Day 28
LogMAR Visual Acuity (LogMAR VA)
Time frame: Measured at Day 0 and Day 28
Proportion of participants losing ≥15 letters of LogMAR VA
Time frame: Measured each day (Day 0 through Day 28)
Compliance rate
Time frame: Measured each day (Day 0 through Day 28)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No. Data will not be shared with other researchers
Related trials for Retinitis Pigmentosa
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Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants
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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.
Hannah Dunbar, PhD principal investigator
UCL Institute of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coloured-light torch and Different coloured-light torch in people with Retinitis Pigmentosa, run by University College, London 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Jan 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pushpsen Joshi (0203 447 5369, uclh.randd@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tritan Colour Contrast Threshold (CCT) (time frame: Measured at Day 0 and Day 28). 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 25 Jan 2024.