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| Name | Class |
|---|---|
| CONET GmbH - Clinical Operations Network | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcorneal Electrostimulation via OkuStim System | Device | Transcorneal electrostimulation, usually applied once per week for 30 min (home-use). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Patients who have been prescribed the OkuStim System and who use the therapy for more than one year are invited to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Hendrik Scholl, Prof. Dr. | Department of Ophthalmology, University of Basel, Switzerland | Principal Investigator |
| Katarina Stingl, Prof. Dr. | University Eye Hospital Tuebingen, Tuebingen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Heidelberg, Augenklinik | Heidelberg | 69120 | Germany | |||
| Klinikum Stuttgart gKAöR, Augenklinik Standort Mitte (Katharinenhospital) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33037922 | Background | 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. | |
| 31775146 |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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| 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. |
| 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. |
| Stuttgart |
| 70174 |
| Germany |
| Universitäts-Augenklinik Tübingen, Abt. für Augenheilkunde | Tübingen | 72076 | Germany |
| Universitätsspital Basel, Augenklinik | Basel | 4031 | Switzerland |
| 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. |
| 28114587 | Background | 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. |
| 21467183 | Background | 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. |
| 32429728 | Background | 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. |
| 31713752 | Background | 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. |
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |