A Pilot, Randomised, Masked Study to Investigate the Effect of Coloured-light on Colour Contrast Thresholds in Retinitis Pigmentosa.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Tritan Colour Contrast Threshold (CCT)
研究概览
简要总结
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).
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Tritan Colour Contrast Threshold (CCT)
时间窗: 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).
次要结局
- 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))