Clinical trial NCT04983914: Retrospective NIS to Evaluate the Patient Benefit of TES
Official title: Retrospective Non-Interventional Study to Evaluate the Patient Benefit of Transcorneal Electrostimulation (TES)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinitis Pigmentosa
Keywords: Transcorneal Electrostimulation
TcES
TES
Inherited retinal dystrophy
Retinopathia pigmentosa
Retinitis pigmentosa
Lead sponsor: Okuvision GmbH
Sponsor class: INDUSTRY
Collaborators: name: CONET GmbH - Clinical Operations Network
First posted: 2021-07-30
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been prescribed the OkuStim System and who use the therapy for more than one year are invited to participate.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Not willing and able to consent

Primary outcomes:
measure: Visual field
timeFrame: 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 outcomes:
measure: Best-corrected visual acuity
timeFrame: 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.
measure: Central foveal thickness
timeFrame: 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.
Other outcomes:
measure: Reasons for discontinuation of therapy and patient satisfaction
timeFrame: 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
measure: Adverse events
timeFrame: 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.
Locations:
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg, Augenklinik
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart gKAöR, Augenklinik Standort Mitte (Katharinenhospital)
city: Tübingen
country: Germany
facility: Universitäts-Augenklinik Tübingen, Abt. für Augenheilkunde
city: Basel
country: Switzerland
facility: Universitätsspital Basel, Augenklinik
Study officials:
affiliation: Department of Ophthalmology, University of Basel, Switzerland
name: Hendrik Scholl, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Eye Hospital Tuebingen, Tuebingen, Germany
name: Katarina Stingl, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zabek O, Camenzind Zuche H, Muller 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.
citation: Jolly JK, Wagner SK, Martus P, MacLaren RE, Wilhelm B, Webster AR, Downes SM, Charbel Issa P, Kellner U, Jagle H, Ruther K, Bertelsen M, Bragadottir R, Prener Holtan J, van den Born LI, Sodi A, Virgili G, Gosheva M, Pach J, Zundorf I, Zrenner E, Gekeler F. Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim(R) System (TESOLA-Study). Ophthalmic Res. 2020;63(3):234-243. doi: 10.1159/000505001. Epub 2019 Nov 26.
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.
citation: Schatz A, Rock 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.
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.
citation: Della Volpe-Waizel M, Zuche HC, Muller 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.