RecruitingNCT07548944

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

Observational Study to Investigate the Short-term Effects of Transcorneal Electrical Stimulation (TES) on Visual Performance in Patients With Retinitis Pigmentosa and Similar Retinal Diseases

Sponsor

Okuvision GmbH

Enrollment

30 participants

Start Date

Apr 20, 2026

Study Type

OBSERVATIONAL

Conditions

Retinitis pigmentosa (RP)Cone-Rod Dystrophy Usher Syndrome

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria4

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

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Interventions

DEVICETranscorneal 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.