Status:
COMPLETED
Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa
Lead Sponsor:
Okuvision GmbH
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
18-80 years
Phase:
NA
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 shor...
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01837901
Start Date
July 1 2011
End Date
February 1 2014
Last Update
March 18 2021
Active Locations (1)
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1
Department für Augenheilkunde, Eberhard-Karls-Universität
Tübingen, Germany, 72076