Retrospective NIS to Evaluate the Patient Benefit of TES

NCT04983914 | Completed

• 1 other identifier: TES-NIS2021
• Study Type: observational
• Target: 49
• Locations: 2 countries
• Sites: 4

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.

Conditions

Retinitis Pigmentosa

Keywords

Transcorneal Electrostimulation; TcES; TES; Inherited retinal dystrophy; Retinopathia pigmentosa; Retinitis pigmentosa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Best-corrected visual acuity

  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.

• Central foveal thickness

  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 (2)

• 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

• Adverse events

  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.

Interventions

Transcorneal Electrostimulation via OkuStim System DEVICE

Transcorneal electrostimulation, usually applied once per week for 30 min (home-use).

Also known as: TcES, TES, OkuStim

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Not willing and able to consent

Sponsors & Collaborators

• Okuvision GmbH: lead
• CONET GmbH - Clinical Operations Network: collaborator

Study Sites (4)

Universitätsklinikum Heidelberg, Augenklinik

Heidelberg, 69120, Germany

Location

Klinikum Stuttgart gKAöR, Augenklinik Standort Mitte (Katharinenhospital)

Stuttgart, 70174, Germany

Location

Universitäts-Augenklinik Tübingen, Abt. für Augenheilkunde

Tübingen, 72076, Germany

Location

Universitätsspital Basel, Augenklinik

Basel, 4031, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 33037922 BACKGROUND

• 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.

  PMID: 31775146 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.

  PMID: 28114587 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.

  PMID: 21467183 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.

  PMID: 32429728 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.

  PMID: 31713752 BACKGROUND

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 30, 2021
• Study Start: September 6, 2021
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); CH (1)