TES for the Treatment of RP (TESOLAUK)
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|ClinicalTrials.gov Identifier: NCT01847365|
Recruitment Status : Completed
First Posted : May 6, 2013
Last Update Posted : November 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa||Device: Transcorneal electrical stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicentre Safety Study of the Okustim® System|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Experimental: Retinitis Pigmentosa
Transcorneal electrical stimulation (TES) administered to one eye for 6 months, followed by monitoring period without treatment for 6 months.
Device: Transcorneal electrical stimulation
Transcorneal electrical stimulation will be delivered by the CE-marked Okustim device.
- Adverse Events [ Time Frame: 12 months ]Quantity and Character of Adverse Events Related to the Use of the Device
- Efficacy of Intervention [ Time Frame: 12 months ]Ophthalmic examination, best corrected visual acuity, visual field assessment, microperimetry, optical coherence tomography, fundus photography
- Usability of the Device [ Time Frame: 12 months ]Non-validated questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847365
|Oxford University Hospitals NHS Trust|
|Oxford, Oxfordshire, United Kingdom, OX3 9DU|
|Moorfields Eye Hospital NHS Foundation Trust|
|London, United Kingdom, EC1V 2PD|
|Study Chair:||Robert E MacLaren, FRCOphth DPhil||University of Oxford, Oxford University Hospitals NHS Trust and Moorfields Eye Hospital NHS Foundation Trust|
|Principal Investigator:||Susan M Downes, FRCOphth MD||Oxford University Hospitals NHS Trust and University of Oxford|
|Principal Investigator:||Andrew R Webster, FRCOphth MD||UCL Institute of Ophthalmology and Moorfields Eye Hospital NHS Foundation Trust|