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Transcorneal Electrical Stimulation - Multicenter Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01835002
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Okuvision GmbH

Study Description
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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.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Device: Transcorneal electrostimulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicenter Safety Study of the Okustim ® System
Study Start Date : September 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • OkuStim
  • TES
  • TcES


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Questionnaires [ Time Frame: 6 months ]
    Questionnaires to collect the patient's perceived benefits of treatment and handling of the device


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835002


Locations
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Denmark
Glostrup Hospital and Kennedy Center
Glostrup, Denmark
Germany
University Eye Clinic Bonn
Bonn, Germany, 53127
Augenzentrum München
Munich, Germany
University Eye Clinic Regensburg
Regensburg, Germany, 93053
Zentrum für seltene Netzhauterkrankungen, AugenZentrum Siegburg
Siegburg, Germany, 53721
Centre for Ophthalmology at the eye clinic Tübingen
Tübingen, Germany, 72076
Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Okuvision GmbH
Investigators
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Principal Investigator: Florian Gekeler, Prof Dr med Eberhard-Karls-Universität Tübingen
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Okuvision GmbH
ClinicalTrials.gov Identifier: NCT01835002    
Other Study ID Numbers: TESOLA
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Keywords provided by Okuvision GmbH:
transcorneal electrostimulation
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
 Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn