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Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Okuvision GmbH
ClinicalTrials.gov Identifier:
NCT01837901
First received: April 9, 2013
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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 Intervention
Retinitis Pigmentosa
Device: transcorneal electrostimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Transkorneale Elektrostimulation Zur Therapie Bei Retinitis Pigmentosa - Eine Prospektive, Randomisierte, Einfach Blinde Folgestudie

Resource links provided by NLM:


Further study details as provided by Okuvision GmbH:

Primary Outcome Measures:
  • Visual Field [ Time Frame: one year ] [ Designated as safety issue: No ]
    Change in the area measured by kinetic visual field measurement


Secondary Outcome Measures:
  • ERG b-wave [ Time Frame: one year ] [ Designated as safety issue: No ]
  • ERG a-wave [ Time Frame: one year ] [ Designated as safety issue: No ]
  • BCVA [ Time Frame: one Year ] [ Designated as safety issue: No ]
    Best corrected visual acuity

  • VFQ-25 [ Time Frame: one year ] [ Designated as safety issue: No ]
    Visual Function Questionnaire (VFQ-25)

  • Dark adaption [ Time Frame: one year ] [ Designated as safety issue: No ]
    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).


Enrollment: 55
Study Start Date: July 2011
Study Completion Date: February 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837901

Locations
Germany
Department für Augenheilkunde, Eberhard-Karls-Universität
Tübingen, Germany, 72076
Sponsors and Collaborators
Okuvision GmbH
Investigators
Principal Investigator: Florian Gekeler, Prof. Dr. Eberhard-Karls-Universität Tübingen
  More Information

Publications:
Responsible Party: Okuvision GmbH
ClinicalTrials.gov Identifier: NCT01837901     History of Changes
Other Study ID Numbers: EST_2
Study First Received: April 9, 2013
Last Updated: April 28, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Okuvision GmbH:
transcorneal electrostimulation

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

ClinicalTrials.gov processed this record on November 25, 2014