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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Weekly stimulation for 30 minutes with current of TES delivered of 150% of the individual phosphene threshold.
Glostrup Hospital and Kennedy Center
Glostrup Municipality, Denmark
University Eye Clinic Bonn
Bonn, Germany
Augenzentrum München
Munich, Germany
University Eye Clinic Regensburg
Regensburg, Germany
ophthalmic examinations
visual acuity slit lamp microscopy for examination of the anterior and posterior segment intraocular pressure measurement visual field examination Optical coherence tomography (OCT) Digital colour fundus photography
Time frame: 6 months
Questionnaires
Questionnaires to collect the patient's perceived benefits of treatment and handling of the device
Time frame: 6 months
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Zentrum für seltene Netzhauterkrankungen, AugenZentrum Siegburg
Siegburg, Germany
Centre for Ophthalmology at the eye clinic Tübingen
Tübingen, Germany
Oslo University Hospital
Oslo, Norway