Observational Study to Investigate the Short-term Effects of Transcorneal Electrical Stimulation on Visual Performance
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOkuvision GmbH
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with retinitis pigmentosa or other similar degenerative retinal disease recruited through Augenzentrum Frankfurt Prof. Koch GmbH, including both existing patients and individuals responding to a public study announcement.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Transcorneal Electrical Stimulation using the OkuStim System
DeviceSingle application of the OkuStim® System for TES therapy in accordance with its intended purpose for 30 minutes. No control or comparative intervention planned.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Best-corrected visual acuity
Measured with ETDRS chart and Manifold Platform
Time frame
- ETDRS: Baseline and approx. 3.5 hours after TES - Manifold Platform: Baseline, immediately after TES, and approx. 3.5 hours after TES2
Contrast sensitivity
Quick contrast sensitivity function (qCSF) measured with Manifold Platform
Time frame
Baseline, immediately after TES, and approx. 3.5 hours after TES3
Retinal sensitivity
Measured with microperimetry
Time frame
Baseline and approx. 3.5 hours after TES4
Subjective changes in visual performance
Questionnaire on perceived changes in visual performance after TES therapy
Time frame
Approx. 3.5 hours after TESOther outcomes
1
Safety
Number and nature of device-related adverse events and serious adverse events
Time frame
3.5 hours after TESSponsors and contacts
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Source ClinicalTrials.gov