Retrospective NIS to Evaluate the Patient Benefit of TES
NCT ID: NCT04983914
Last Updated: 2022-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
49 participants
OBSERVATIONAL
2021-09-06
2022-08-19
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Transcorneal Electrostimulation via OkuStim System
Transcorneal electrostimulation, usually applied once per week for 30 min (home-use).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to consent
Exclusion Criteria
ALL
No
Sponsors
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CONET GmbH - Clinical Operations Network
UNKNOWN
Okuvision GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Hendrik Scholl, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, University of Basel, Switzerland
Katarina Stingl, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Eye Hospital Tuebingen, Tuebingen, Germany
Locations
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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
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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TES-NIS2021
Identifier Type: -
Identifier Source: org_study_id
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