Transcorneal Electrical Stimulation - Multicenter Safety Study

Not Applicable

Completed

• Conditions: Retinitis Pigmentosa
• Interventions: Device: Transcorneal electrostimulation

• Registration Number: NCT01835002
• Lead Sponsor: Okuvision GmbH

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-18
• Primary Completion: 2014-07
• Study Completion: 2015-08
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OkuStim	Transcorneal electrostimulation	Electrostimulation Standard Treatment with OkuStim

Primary Outcome Measures

Name	Time	Method
ophthalmic examinations	6 months	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

Secondary Outcome Measures

Name	Time	Method
Questionnaires	6 months	Questionnaires to collect the patient's perceived benefits of treatment and handling of the device

Trial Locations

Locations (7)

Augenzentrum München; 🇩🇪 Munich, Germany

Glostrup Hospital and Kennedy Center; 🇩🇰 Glostrup, Denmark

University Eye Clinic Regensburg; 🇩🇪 Regensburg, Germany

Zentrum für seltene Netzhauterkrankungen, AugenZentrum Siegburg; 🇩🇪 Siegburg, Germany

Centre for Ophthalmology at the eye clinic Tübingen; 🇩🇪 Tübingen, Germany

Oslo University Hospital; 🇳🇴 Oslo, Norway

University Eye Clinic Bonn; 🇩🇪 Bonn, Germany