Extrait

Background and study aims Retinitis pigmentosa (RP) is a progressive degenerative eye disease that affects the retina, which often leads to blindness. 1 in 4000 people in the UK is affected by RP yet there is no established therapy for treating or delaying its progression.Transcorneal electrical stimulation (TES) has gained attention as a possible treatment option for RP. Research has shown that TES improves retinal cell viability and visual function. An initial small 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 study the benefits of TES on a larger scale. Who can participate? Male or female participants of 18 years of age or more with retinitis pigmentosa (diagnosed by an ophthalmologist). 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. What does the study involve? All 12 recruited participants will undergo weekly TES of one 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. What are the possible benefits and risks of participating? TES has been shown to improve the visual fields. TES may improve the sharpness of vision. TES will be delivered by the CE-marked Okustim device. Previous studies have demonstrated TES to be a low risk treatment. Some patients may experience irritation of the eye or a dry eye, which can be treated with artificial tears. Some participants have reported a 'prickly' sensation when the stimulation is applied. When is the study starting and how long is it expected to run for? Recruitment into the study will begin in May 2013. 12 participants will be enrolled for 1 year. Where is the study run from? Participants will be enrolled for 1 year across two sites in the UK - the Oxford Eye Hospital and London Moorfields Eye Hospital. Who is funding the study? Biomedical Research Centre Oxford and Okuvision GmbH. Who is the main contact? Professor Robert Maclaren (Chief Investigator) [email protected]

Critère d'inclusion

• Retinitis pigmentosa

Liens

• ictrp
• isrctn