Retrospective Non-Interventional Study to Evaluate the Patient Benefit of Transcorneal Electrostimulation (TES)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Retinitis Pigmentosa
- Sponsor
- Okuvision GmbH
- Enrollment
- 49
- Locations
- 4
- Primary Endpoint
- Visual field
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
In this retrospective non-interventional study (NIS), the subjective and objective benefit of patients with retinitis pigmentosa (and other dystrophies like Usher, Choroideremia or cone-rod dystrophy), who have been prescribed the therapy of transcorneal electrostimulation (TcES) with the OkuStim System, is assessed.
Detailed Description
The medical device OkuStim received the CE mark (a symbol of free marketability in the European Economic Area) in 2011 and is commercially available for patients in Europe since 2014. Since then, patients with retinitis pigmentosa and other dystrophies have regularly applied the therapy of transcorneal electrostimulation (TcES) with OkuStim. So far, the benefits of the therapy and the experiences of the patients with regular, multi-year use have not been systematically recorded. In this retrospective non-interventional study (NIS) with patients which have been using TcES since \>1 year, data present for visual field, best-corrected visual acuity (BCVA) and central foveal thickness (as assessed via OCT) is collected. In addition, reasons for discontinuation of therapy and patient satisfaction with TcES are assessed via a questionnaire. Side-effects are also recorded, if present in the patient files.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Use of TcES for \>1year
- •Willing and able to consent
Exclusion Criteria
- •Not willing and able to consent
Outcomes
Primary Outcomes
Visual field
Time Frame: Baseline and then all data present in patient files after begin of therapy. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy.
Assessment of changes compared to baseline (before TcES was started)
Secondary Outcomes
- Central foveal thickness(Baseline and then all data present in patient files after begin of therapy. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy.)
- Best-corrected visual acuity(Baseline and then all data present in patient files after begin of therapy. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy.)