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Transcorneal Electrical Stimulation - Multicenter Safety Study

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ClinicalTrials.gov Identifier: NCT01835002
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the long term effects of transcorneal electrostimulation (TES) in patients with retinitis pigmentosa (RP). In a prior study (NCT00804102) the results of short term stimulation pointed to a positive effect on the visual field and other parameters. In this study, the patients will be stimulated with the OkuStim device for half a year and safety parameters will be measured.

Condition or disease Intervention/treatment
Retinitis Pigmentosa Device: Electrostimulation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
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
Primary Completion Date : July 2014
Study Completion Date : August 2015


Arms and Interventions

Arm Intervention/treatment
Experimental: OkuStim
Electrostimulation Standard Treatment with OkuStim
Device: Electrostimulation
Other Name: OkuStim


Outcome Measures

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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

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

Publications:
Responsible Party: Okuvision GmbH
ClinicalTrials.gov Identifier: NCT01835002     History of Changes
Other Study ID Numbers: TESOLA
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Keywords provided by Okuvision GmbH:
transcorneal electrostimulation

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn