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
Qualifiers
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 design
Treatments tested in this trial
- Transcorneal Electrical Stimulation using the OkuStim System
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov