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
Okuvision GmbH · NCT07548944
This study will see if a 30-minute session of transcorneal electrical stimulation with the OkuStim device produces short-term vision improvements in adults with retinitis pigmentosa or similar retinal degenerations who already use the device.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Okuvision GmbH (industry) |
| Locations | 1 site (Frankfurt am Main) |
| Trial ID | NCT07548944 on ClinicalTrials.gov |
What this trial studies
This open-label observational study enrolls adults with retinitis pigmentosa or related degenerative retinal diseases who are current users of the OkuStim system and report short-term subjective effects after treatment. Participants complete a questionnaire, undergo baseline ophthalmic tests (slit-lamp exam, best-corrected visual acuity, quick contrast sensitivity function, kinetic perimetry, microperimetry), receive a 30-minute TES session with OkuStim, and then have key vision tests repeated. After a ~3.5-hour break and a second questionnaire about perceived changes, final examinations are performed to capture any persisting short-term effects. The goal is to quantify reported immediate vision changes and contribute data toward understanding TES mechanisms.
Who should consider this trial
Good fit: Adults (≥18) with clinically diagnosed retinitis pigmentosa or similar degenerative retinal disease who currently use the OkuStim system and report short-term vision changes after treatment are ideal candidates.
Not a fit: Patients who do not use OkuStim, do not notice any short-term changes after stimulation, have other ocular diseases that confound measurements, or have cognitive or medical conditions preventing participation are unlikely to benefit.
Why it matters
Potential benefit: If successful, the study could confirm and quantify short-term vision improvements after TES and help clinicians and patients optimize symptom management and timing of therapy.
How similar studies have performed: TES has regulatory CE-mark approval for slowing longer-term progression and there are anecdotal reports of immediate subjective improvements, but short-term effects have not been systematically measured in controlled investigations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Frankfurt am Main
- Augenzentrum Frankfurt Prof. Koch GmbH — Frankfurt am Main, Germany (RECRUITING)
Study contacts
- Principal investigator: Dr. med. Svenja Deuchler — Augenzentrum Frankfurt Prof. Koch GmbH
- Study coordinator: Claudia Büdel
- Email: info@azffm.de
- Phone: +49 69 7566 8880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Retinitis Pigmentosa, Usher Syndrome, Cone Rod Dystrophy, Transcorneal Electrical Stimulation, TES, OkuStim, Okuvision, Retinitis pigmentosa