Retinitis Pigmentosa Clinical Trial
Official title:
Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicentre Safety Study of the Okustim® System
Retinitis pigmentosa (RP) is a progressive degenerative disease of the retina, which often
leads to blindness. 1 in 4000 people in the UK are affected by RP yet there is no established
therapy for treating or delaying its progression.
Transcorneal electrical stimulation (TES) has garnered attention as a possible therapeutic
option for RP. Research has shown that TES improves retinal cell viability and visual
function. An initial pilot study of TES on 24 participants with RP demonstrated that it was
safe and improved vision.
This study aims to confirm the safety of the new CE-approved Okustim device and to further
characterise the benefits of TES on a larger scale. 12 participants will be enrolled for 1
year across two sites in the UK - the Oxford Eye Hospital and London Moorfields Eye Hospital.
Recruited participants will undergo weekly TES of 1 eye for 30 minutes for a period of 6
months. This will be followed by a further 6 months of observation without stimulation giving
a total participation time of 1 year. Participants will be assessed at 3, 6, 9 and 12 months
after their initial baseline visit by clinical examination, investigations and
questionnaires.
Participants should have a diagnosis of RP and be capable of giving consent. Participants, or
a carer, should have sufficient motor skills to attach the device themselves. As this study
seeks to ascertain the impact of TES on RP, participants with other eye diseases (e.g.
diabetic retinopathy) cannot be included in the study.
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