Trial record 13 of 199 for:    "Eye Diseases, Hereditary" OR "Peters plus syndrome"

Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Okuvision GmbH
ClinicalTrials.gov Identifier:
NCT01837901
First received: April 9, 2013
Last updated: April 22, 2013
Last verified: April 2013
  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
Estimated Study Completion Date: February 2014
Estimated 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
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 22, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Okuvision GmbH:
transcorneal electrostimulation

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

ClinicalTrials.gov processed this record on April 15, 2014