Study to Explore Short-term Effects of Transcorneal Electrical Stimulation with the OkuStim System on Vision in Adults with Retinitis Pigmentosa and Similar Retinal Diseases

What this Trial Is About

This research aims to explore the short-term effects of transcorneal electrical stimulation TES on visual performance in patients with retinitis pigmentosa and similar degenerative retinal diseases such as Usher syndrome and cone rod dystrophy. These conditions cause progressive vision loss, and while TES therapy using the CE-marked OkuStim System is approved in the EU for slowing disease progression, patients often report short-term improvements that have not been systematically studied. The study seeks to objectively measure and quantify these subjective short-term effects. Participants already using the OkuStim System will take part in an open-label observational study. They will complete a questionnaire on their experiences with short-term effects from TES. Eligible participants will undergo baseline eye exams, including slit-lamp examination, best-corrected visual acuity BCVA, contrast sensitivity, kinetic perimetry, and microperimetry. They will then receive a 30-minute TES treatment using the OkuStim System as prescribed. After treatment, key vision tests will be repeated immediately and again approximately 3.5 hours later, along with a second questionnaire to assess perceived changes. Throughout the study, participants will be monitored with various visual assessments to understand TESs short-term impact. These include BCVA, contrast sensitivity, retinal sensitivity, and subjective evaluations of visual performance. The study involves detailed ophthalmologic evaluations before and after treatment, aiming to clarify TESs mechanisms. The total participation includes treatment and assessments completed on the same day, with no long-term follow-up described.

Observational Study to Investigate the Short-term Effects of Transcorneal Electrical Stimulation on Visual Performance