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Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Safety and Efficacy Multicenter Study

NCT02548572 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-05-01

No results posted yet for this study

Summary

Several studies have shown that TES in RP patients may help to slow the progressive deterioration of this degenerative disease. The end point of this clinical trial is to slow or stop disease progression with weekly treatment using TES for 1 year.

Conditions

Interventions

DEVICE

Transcorneal Electrical Stimulation using Okustim device

The Okustim® stimulation device is a battery-powered electronic neuro-stimulator, which delivers a weak electrical pulse. This current is delivered to the eyes by the OkuStim® device using the "OkuEl®" electrodes, which are held in place via the "OkuSpex®" frame. In this study the treatment level will be held constant at 0.8 mA for all study subjects. After switching on the neuro-stimulator, the subject's retina will be stimulated through specific electrodes (OkuEl, held in position by the OkuSpex) worn on the face with the predetermined intensity and time period (delivered by the OkuStim device).

Sponsors & Collaborators

  • Okuvision GmbH

    collaborator INDUSTRY

  • Wills Eye

    lead OTHER

Principal Investigators

  • Leslie Hyman, PhD · Wills Eye Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02548572 on ClinicalTrials.gov