Transcorneal Electrical Stimulation - Multicenter Safety Study

Study Overview
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Brief Summary
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The purpose of this study is to expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP.

Detailed Description
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This is a single-arm open label interventional safety trial with RP patients, who receive weekly TES for 6 months on 1 eye followed by observation for another 6 months without stimulation. The primary outcome measure is safety, indicated by the frequency and severity of adverse events.

Official Title
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Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicenter Safety Study of the Okustim ® System

Conditions
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Retinitis Pigmentosa

Intervention / Treatment
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* Device: Transcorneal electrostimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with retinitis pigmentosa (rod-cone dystrophy) after prescription of electrical stimulation by an ophthalmologist adult patients who are capable of giving consent, Visual acuity ≥ 0.02 because the electrode is to be positioned on the eye at home, the patient or his family members should have sufficient fine motor skills (assessment by the study physician) the patient must be capable of giving consent and a medical assessment that he/she is able to participate in the whole study according to the protocol Exclusion Criteria: diabetic retinopathy neovascularisation of any origin after arterial or venous occlusion after retinal detachment silicone oil tamponade dry or exudative age-related macular degeneration macular edema all forms of glaucoma any form of corneal degeneration that reduces visual acuity systemic diseases that are difficult to control or manage, that could endanger the normal study schedule patients in a permanently poor general condition, which could hinder the regular attendance at control examinations in the clinic forms of mental illness related to the bipolar affective and schizoid-affective disorders, and all forms of dementia simultaneous participation in another interventional study or history of interventions whose effect may still persist

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OkuStim<br>Electrostimulation Standard Treatment with OkuStim | Device: Transcorneal electrostimulation<br>* Weekly stimulation for 30 minutes with current of TES delivered of 150% of the individual phosphene threshold.<br>* Other names: TcES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ophthalmic examinations | visual acuity slit lamp microscopy for examination of the anterior and posterior segment intraocular pressure measurement visual field examination Optical coherence tomography (OCT) Digital colour fundus photography | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaires | Questionnaires to collect the patient's perceived benefits of treatment and handling of the device | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcorneal electrostimulation