Coloured-light in Retinitis Pigmentosa.

NCT06224114 | Unknown DMC

• 1 other identifier: 161090
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Retinitis Pigmentosa

Keywords

Inherited eye disease; Retinal dystrophy; Retinitis Pigmentosa; Visual impairment; Photobiomodulation; Mitochondrial Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 at Day 0 and Day 28

Secondary Outcomes (4)

• Protan CCT

  Measured at Day 0 and Day 28

• LogMAR Visual Acuity (LogMAR VA)

  Measured at Day 0 and Day 28

• Proportion of participants losing ≥15 letters of LogMAR VA

  Measured each day (Day 0 through Day 28)

• Compliance rate

  Measured each day (Day 0 through Day 28)

Study Arms (2)

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.

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.

Device: Different coloured-light torch

Interventions

Coloured-light torch DEVICE

Participant administered, at-home, 3-minute daily morning application (between 8 - 10am) of a coloured-light torch to the study eye.

Coloured light 1 group

Different coloured-light torch DEVICE

Participant administered, at-home, 3-minute daily morning application (between 8 - 10am) of a different coloured-light torch to the study eye.

Coloured light 2 group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Retinitis Pigmentosa; Retinal Dystrophies; Vision Disorders; Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hannah Dunbar, PhD

  UCL Institute of Ophthalmology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pushpsen Joshi

CONTACT

0203 447 5369; uclh.randd@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Technicians responsible for study measurements, Chief Investigator (CI), Principal Investigator (PI) and collaborators will be masked to the treatment allocation. It is not possible for participants to be fully masked as they will know which wavelength (colour) of light they have been provided, but they will not be told which wavelength of light is the active intervention. Participants will be advised not to discuss the colour of light used with the masked technicians and study team members.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 25, 2024
• Study Start: March 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)