NCT04983914

Retrospective NIS to Evaluate the Patient Benefit of TES

Retrospective Non-Interventional Study to Evaluate the Patient Benefit of Transcorneal Electrostimulation (TES)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: Okuvision GmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
DEVICE	Transcorneal Electrostimulation via OkuStim System	Transcorneal electrostimulation, usually applied once per week for 30 min (home-use).

Timeline

• Start date: 2021-09-06
• Primary completion: 2022-08-19
• Completion: 2022-08-19
• First posted: 2021-07-30
• Last updated: 2022-08-22

Locations

4 sites across 2 countries: Germany, Switzerland