Status:
COMPLETED
Transcorneal Electrical Stimulation - Multicenter Safety Study
Lead Sponsor:
Okuvision GmbH
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP.
Detailed Description
This is a single-arm open label interventional safety trial with RP patients, who receive weekly TES for 6 months on 1 eye followed by observation for another 6 months without stimulation. The primary...
Eligibility Criteria
Inclusion
- patients with retinitis pigmentosa (rod-cone dystrophy) after prescription of electrical stimulation by an ophthalmologist
- adult patients who are capable of giving consent,
- Visual acuity ≥ 0.02
- because the electrode is to be positioned on the eye at home, the patient or his family members should have sufficient fine motor skills (assessment by the study physician)
- the patient must be capable of giving consent and a medical assessment that he/she is able to participate in the whole study according to the protocol
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 :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01835002
Start Date
September 1 2012
End Date
August 1 2015
Last Update
March 4 2021
Active Locations (7)
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1
Glostrup Hospital and Kennedy Center
Glostrup Municipality, Denmark
2
University Eye Clinic Bonn
Bonn, Germany, 53127
3
Augenzentrum München
Munich, Germany
4
University Eye Clinic Regensburg
Regensburg, Germany, 93053