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

Okuvision GmbH7 sites in 3 countries105 target enrollmentSeptember 2012

ConditionsRetinitis Pigmentosa

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Retinitis Pigmentosa
Sponsor: Okuvision GmbH
Enrollment: 105
Locations: 7
Primary Endpoint: ophthalmic examinations
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

August 2015

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Okuvision GmbH

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

ophthalmic examinations

Time Frame: 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