Transcorneal Electrical Stimulation - Multicenter Safety Study

March 2, 2021 updated by: Okuvision GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark
        • Glostrup Hospital and Kennedy Center
  • Germany
      • Bonn, Germany, 53127
        • University Eye Clinic Bonn
      • Munich, Germany
        • Augenzentrum München
      • Regensburg, Germany, 93053
        • University Eye Clinic Regensburg
      • Siegburg, Germany, 53721
        • Zentrum für seltene Netzhauterkrankungen, AugenZentrum Siegburg
      • Tübingen, Germany, 72076
        • Centre for Ophthalmology at the eye clinic Tübingen
  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OkuStim
Electrostimulation Standard Treatment with OkuStim
Device: Transcorneal electrostimulation
Weekly stimulation for 30 minutes with current of TES delivered of 150% of the individual phosphene threshold.
Other Names:
  • TES
  • OkuStim
  • TcES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okuvision GmbH

Investigators

  • Principal Investigator: Florian Gekeler, Prof Dr med, Eberhard-Karls-Universität Tübingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimate)

April 18, 2013

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TESOLA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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