RecruitingNot Applicable

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

Germany30 participantsStarted 2026-04-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Best-corrected visual acuity

Timeframe: - ETDRS: Baseline and approx. 3.5 hours after TES - Manifold Platform: Baseline, immediately after TES, and approx. 3.5 hours after TES

Contrast sensitivity

Timeframe: Baseline, immediately after TES, and approx. 3.5 hours after TES

Retinal sensitivity

Timeframe: Baseline and approx. 3.5 hours after TES

Subjective changes in visual performance

Timeframe: Approx. 3.5 hours after TES

Trial details

NCT IDNCT07548944

SponsorOkuvision GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-03

Contact for this trial

Claudia Büdel

+49 69 7566 8880 info@azffm.de

View on ClinicalTrials.gov More Retinitis Pigmentosa (RP) trials