Retrospective NIS to Evaluate the Patient Benefit of TES

Completed

• Conditions: Retinitis Pigmentosa

• Registration Number: NCT04983914
• Lead Sponsor: Okuvision GmbH

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.

Study Timeline

• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-07-30
• Study Start: 2021-09-06
• Status Verified: 2022-08
• Primary Completion: 2022-08-19
• Study Completion: 2022-08-19
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Use of TcES for >1year
• Willing and able to consent

Exclusion Criteria

• Not willing and able to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual field	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 Outcome Measures

Name	Time	Method
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.	Assessment of changes compared to baseline (before TcES was started)
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.	Assessment of changes compared to baseline (before TcES was started)

Trial Locations

Locations (4)

Universitätsklinikum Heidelberg, Augenklinik; 🇩🇪 Heidelberg, Germany

Klinikum Stuttgart gKAöR, Augenklinik Standort Mitte (Katharinenhospital); 🇩🇪 Stuttgart, Germany

Universitäts-Augenklinik Tübingen, Abt. für Augenheilkunde; 🇩🇪 Tübingen, Germany

Universitätsspital Basel, Augenklinik; 🇨🇭 Basel, Switzerland