Retrospective NIS to Evaluate the Patient Benefit of TES

Retinitis Pigmentosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04983914
• Other study ID #: TES-NIS2021
• Status: Completed
• Start date: September 6, 2021
• Est. completion date: August 19, 2022

Study information

• Verified date: August 2022
• Source: Okuvision GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 19, 2022
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Use of TcES for >1year

• Willing and able to consent

Exclusion Criteria:

• Not willing and able to consent

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Device:
• Transcorneal Electrostimulation via OkuStim System
Transcorneal electrostimulation, usually applied once per week for 30 min (home-use).

Locations

Country	Name	City	State
Germany	Universitätsklinikum Heidelberg, Augenklinik	Heidelberg
Germany	Klinikum Stuttgart gKAöR, Augenklinik Standort Mitte (Katharinenhospital)	Stuttgart
Germany	Universitäts-Augenklinik Tübingen, Abt. für Augenheilkunde	Tübingen
Switzerland	Universitätsspital Basel, Augenklinik	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Okuvision GmbH	CONET GmbH - Clinical Operations Network

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (6)

Della Volpe-Waizel M, Zuche HC, Müller U, Rickmann A, Scholl HPN, Todorova MG. Metabolic monitoring of transcorneal electrical stimulation in retinitis pigmentosa. Graefes Arch Clin Exp Ophthalmol. 2020 Jan;258(1):79-87. doi: 10.1007/s00417-019-04522-9. Epub 2019 Nov 12. — View Citation

Jolly JK, Wagner SK, Martus P, MacLaren RE, Wilhelm B, Webster AR, Downes SM, Charbel Issa P, Kellner U, Jägle H, Rüther K, Bertelsen M, Bragadóttir R, Prener Holtan J, van den Born LI, Sodi A, Virgili G, Gosheva M, Pach J, Zündorf I, Zrenner E, Gekeler F. Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim® System (TESOLA-Study). Ophthalmic Res. 2020;63(3):234-243. doi: 10.1159/000505001. Epub 2019 Nov 26. — View Citation

Schatz A, Pach J, Gosheva M, Naycheva L, Willmann G, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Messias A, Gekeler F. Transcorneal Electrical Stimulation for Patients With Retinitis Pigmentosa: A Prospective, Randomized, Sham-Controlled Follow-up Study Over 1 Year. Invest Ophthalmol Vis Sci. 2017 Jan 1;58(1):257-269. doi: 10.1167/iovs.16-19906. — View Citation

Schatz A, Röck T, Naycheva L, Willmann G, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Messias A, Gekeler F. Transcorneal electrical stimulation for patients with retinitis pigmentosa: a prospective, randomized, sham-controlled exploratory study. Invest Ophthalmol Vis Sci. 2011 Jun 23;52(7):4485-96. doi: 10.1167/iovs.10-6932. — View Citation

Sinim Kahraman N, Oner A. Effect of Transcorneal Electrical Stimulation on Patients with Retinitis Pigmentosa. J Ocul Pharmacol Ther. 2020 Oct;36(8):609-617. doi: 10.1089/jop.2020.0017. Epub 2020 May 19. — View Citation

Zabek O, Camenzind Zuche H, Müller U, Scholl HPN, Rickmann A, Della Volpe Waizel M. Optical coherence tomography angiography findings in patients undergoing transcorneal electrical stimulation for treating retinitis pigmentosa. Graefes Arch Clin Exp Ophthalmol. 2021 May;259(5):1167-1177. doi: 10.1007/s00417-020-04963-7. Epub 2020 Oct 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reasons for discontinuation of therapy and patient satisfaction	Custom-made questionnaire to assess reasons for discontinuation of therapy and patient satisfaction	Patients are asked to fill out the questionnaire once. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy
Other	Adverse events	Adverse events will be recorded if present in the patient files. Only device-related adverse events will be analyzed	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.
Primary	Visual field	Assessment of changes compared to baseline (before TcES was started)	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.
Secondary	Best-corrected visual acuity	Assessment of changes compared to baseline (before TcES was started)	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.
Secondary	Central foveal thickness	Assessment of changes compared to baseline (before TcES was started)	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.