Retinitis Pigmentosa (RP)Usher SyndromeCone Rod Dystrophy
Investigational drug(s) / intervention(s)
Transcorneal Electrical Stimulation using the OkuStim System
Transcorneal Electrical Stimulation using the OkuStim System: Single application of the OkuStim® System for TES therapy in accordance with its intended purpose for 30 minutes.
No control or comparative intervention planned.
Study summary
Retinitis pigmentosa and similar degenerative diseases of the retina lead to progressive loss of vision. TES therapy with the CE-marked OkuStim® System is a treatment approved in the EU for slowing the progression of the disease. Patients increasingly report short-term subjective improvements in vision, which have not yet been systematically investigated. This exploratory study is conducted to determine whether these subjective short-term effects can be measured, and therefore also be quantified, by objective tests.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Adult patients (≥ 18 years) with clinically diagnosed retinitis pigmentosa (RP) or other similar degenerative retinal disease
* Current treatment with TES using the OkuStim® System within the intended purpose
* Subjective perception of short-term effects after TES treatment
* Ability and willingness to give informed consent
Exclusion Criteria:
* Cognitive, psychological, or linguistic limitations that prevent informed consent or proper study participation
* Presence of other eye diseases (e.g., cataract, glaucoma, macular degeneration) that, in the opinion of the investigator, compromise or confound study assessments
* Simultaneous participation in other clinical studies that could influence the results of the study
* Severe comorbidities that could compromise patient safety or study conduct
Primary outcome measure(s)
Best-corrected visual acuity — - ETDRS: Baseline and approx. 3.5 hours after TES - Manifold Platform: Baseline, immediately after TES, and approx. 3.5 hours after TES Measured with ETDRS chart and Manifold Platform
Contrast sensitivity — Baseline, immediately after TES, and approx. 3.5 hours after TES Quick contrast sensitivity function (qCSF) measured with Manifold Platform
Retinal sensitivity — Baseline and approx. 3.5 hours after TES Measured with microperimetry
Subjective changes in visual performance — Approx. 3.5 hours after TES Questionnaire on perceived changes in visual performance after TES therapy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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