Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa

February 23, 2021 updated by: Okuvision GmbH

Transkorneale Elektrostimulation Zur Therapie Bei Retinitis Pigmentosa - Eine Prospektive, Randomisierte, Einfach Blinde Folgestudie

The purpose of this study is to determine the long-term effects of transcorneal electrostimulation (TcES) in patients with retinitis pigmentosa (RP). In a prior study (NCT00804102) the results of short-term stimulation showed a positive effect on the visual field and other parameters. In this study, the patients will be stimulated with either 0%, 150% or 200% of the individually determined phosphene threshold.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was performed at the Centre for Ophthalmology, University of Tübingen, Germany. The protocol was approved by the local ethics committee. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. Informed consent was obtained from all patients for being included in the study. The study was conducted according to the standards of GCP, the European Union Directive for Medical Devices, and the German Medical Product Law.

Patients were seen at 14 visits over a period of 78 weeks: one baseline visit (screening), followed by 12 visits (in week 1-4 weekly, then in weeks 10, 16, 22, 28, 34, 40, 46 and 52; dates varied a maximum of ± 1 week) including application of TcES for 52 weeks and one follow-up visit (in week 78, dates varied a maximum of ± 1 week).

After inclusion patients were randomly assigned to TcES with 0 mA (sham), 150% or 200% of their individual electrical phosphene threshold (EPT) current at 20 Hz.

Patients and technicians who performed kinetic perimetry, as well as full-field electrophysiology (ERG), multifocal ERG (mfERG) and dark adaptation, were blinded to the treatment group for the entire study period. The physicians who performed all other examinations and TcES were not blinded to study treatment because they were responsible for setting the stimulation parameters.

Study Type

Interventional

Enrollment (Actual)

88

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

  • Germany
      • Tübingen, Germany, 72076
        • Department für Augenheilkunde, Eberhard-Karls-Universität

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult subject with RP (rod-cone dystrophy)
  • BCVA 0.02 to 0.9
  • Reliable visual field measurements
  • Reliable ERG measurements
  • Skillful enough to use the device at home
  • Able to give consent and take part during the whole study

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham
OkuStim is used to determine the phosphene threshold, device is turned on but no stimulation is performed.
Device: Transcorneal electrostimulation
Other Names:
  • TES
  • OkuStim
  • TcES
Experimental: 150%
OkuStim is used to determine the phosphene threshold, and then to administer transcorneal electrostimulation with a stimulation strength corresponding to 150% of the patient's phosphene threshold.
Device: Transcorneal electrostimulation
Other Names:
  • TES
  • OkuStim
  • TcES
Experimental: 200%
OkuStim is used to determine the phosphene threshold, and then to administer transcorneal electrostimulation with a stimulation strength corresponding to 200% of the patient's phosphene threshold.
Device: Transcorneal electrostimulation
Other Names:
  • TES
  • OkuStim
  • TcES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Field, III4e
Time Frame: one year
Change in the area measured by kinetic visual field measurement
one year
Visual Field, V4e
Time Frame: one year
Change in the area measured by kinetic visual field measurement
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ERG B-wave
Time Frame: one year
one year
ERG A-wave
Time Frame: one year
one year
BCVA
Time Frame: one year
Best corrected visual acuity
one year
VFQ-25
Time Frame: one year
Visual Function Questionnaire (VFQ-25)
one year
Dark Adaptation
Time Frame: one year
Adaptation time, changes in pupil diameter, threshold to fullfield blue and red light is measured with a fullfield stimulus threshold test (FST) on the ESPION ERG machine (Diagnosys).
one year

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., 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

July 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 23, 2013

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EST2

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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