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Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa

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: NCT01837901
Recruitment Status : Completed
First Posted : April 23, 2013
Results First Posted : March 18, 2021
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Okuvision GmbH

Brief Summary:
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transkorneale Elektrostimulation Zur Therapie Bei Retinitis Pigmentosa - Eine Prospektive, Randomisierte, Einfach Blinde Folgestudie
Study Start Date : July 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


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:
  • OkuStim
  • TES
  • 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:
  • OkuStim
  • TES
  • 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:
  • OkuStim
  • TES
  • TcES




Primary Outcome Measures :
  1. Visual Field, III4e [ Time Frame: one year ]
    Change in the area measured by kinetic visual field measurement

  2. Visual Field, V4e [ Time Frame: one year ]
    Change in the area measured by kinetic visual field measurement


Secondary Outcome Measures :
  1. ERG B-wave [ Time Frame: one year ]
  2. ERG A-wave [ Time Frame: one year ]
  3. BCVA [ Time Frame: one year ]
    Best corrected visual acuity

  4. VFQ-25 [ Time Frame: one year ]
    Visual Function Questionnaire (VFQ-25)

  5. 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).



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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:

  • 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

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): NCT01837901


Locations
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Germany
Department für Augenheilkunde, Eberhard-Karls-Universität
Tübingen, Germany, 72076
Sponsors and Collaborators
Okuvision GmbH
Investigators
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Principal Investigator: Florian Gekeler, Prof. Dr. Eberhard-Karls-Universität Tübingen
Publications of Results:
Other Publications:
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Responsible Party: Okuvision GmbH
ClinicalTrials.gov Identifier: NCT01837901    
Other Study ID Numbers: EST2
First Posted: April 23, 2013    Key Record Dates
Results First Posted: March 18, 2021
Last Update Posted: March 18, 2021
Last Verified: February 2021
Keywords provided by Okuvision GmbH:
Transcorneal electrostimulation
TcES
TES
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