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Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa

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ClinicalTrials.gov Identifier: NCT01837901
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : April 29, 2014
Sponsor:
Information provided by (Responsible Party):
Okuvision GmbH

Study Description
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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 either 0%, 150% or 200% of the individually determined phosphene threshold.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 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

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Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Sham
No stimulation transcorneal electrostimulation
 Device: transcorneal electrostimulation
OkuStim is used to determine the phosphene threshold, and then to administer electrostimulation
Other Names:
  • OkuStim
  • TES
Experimental: 150%
transcorneal electrostimulation with 150% of phosphene threshold
 Device: transcorneal electrostimulation
OkuStim is used to determine the phosphene threshold, and then to administer electrostimulation
Other Names:
  • OkuStim
  • TES
Experimental: 200%
transcorneal electrostimulation with 200% of phosphene threshold
 Device: transcorneal electrostimulation
OkuStim is used to determine the phosphene threshold, and then to administer electrostimulation
Other Names:
  • OkuStim
  • TES


Outcome Measures
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Primary Outcome Measures :
  1. Visual Field [ 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 adaption [ Time Frame: one year ]
    Adaption 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).


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:

  • 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
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): 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
More Information
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Publications:

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Responsible Party: Okuvision GmbH
ClinicalTrials.gov Identifier: NCT01837901    
Other Study ID Numbers: EST_2
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: April 29, 2014
Last Verified: April 2014
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