Transcorneal Electrical Stimulation - Multicenter Safety Study

Okuvision

Status: Completed

Conditions: Retinitis Pigmentosa

Treatments: Device: Transcorneal electrostimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01835002

TESOLA

Details and patient eligibility

About

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.

Full 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 outcome measure is safety, indicated by the frequency and severity of adverse events.

Enrollment: 105 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

OkuStim

Experimental group

Description:

Electrostimulation Standard Treatment with OkuStim

Treatment:

Device: Transcorneal electrostimulation