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Retinitis PigmentosaNCT04983914

Retrospective NIS to Evaluate the Patient Benefit of TES

An observational study of Retinitis Pigmentosa, run by Okuvision GmbH at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Retinitis Pigmentosa
What is being tested?
Transcorneal Electrostimulation via OkuStim System
Type of treatment
Medical device
How many people
49 participants
Where
4 sitesin 2 countries
Study dates
6 Sep 2021to 19 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients who have been prescribed the OkuStim System and who use the therapy for more than one year are invited to participate.

Who may be able to join

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

Who cannot join

  • Not willing and able to consent

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Germany3 sites

  • Universitätsklinikum Heidelberg, Augenklinik

    Heidelberg, 69120

  • Klinikum Stuttgart gKAöR, Augenklinik Standort Mitte (Katharinenhospital)

    Stuttgart, 70174

  • Universitäts-Augenklinik Tübingen, Abt. für Augenheilkunde

    Tübingen, 72076

Other trials in Germany

Switzerland1 site

  • Universitätsspital Basel, Augenklinik

    Basel, 4031

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Transcorneal Electrostimulation via OkuStim System
Keywords
Transcorneal Electrostimulation, TcES, TES, Inherited retinal dystrophy, Retinopathia pigmentosa, Retinitis pigmentosa
Medical subject headings
Retinitis Pigmentosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcorneal Electrostimulation via OkuStim SystemDevice

    Also called TcES, TES, OkuStim

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual field

    Assessment of changes compared to baseline (before TcES was started)

    Measured: 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)

  1. Best-corrected visual acuity

    Assessment of changes compared to baseline (before TcES was started)

    Measured: 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.

  2. Central foveal thickness

    Assessment of changes compared to baseline (before TcES was started)

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2021
  2. Study start6 Sep 2021
  3. Primary completion19 Aug 2022
  4. Study completion19 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04983914
Sponsor's protocol ID
TES-NIS2021
Status last verified
Aug 2022
First submitted
21 Jul 2021
Last updated
22 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33037922

  • 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.

    PubMed 31775146

  • 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.

    PubMed 28114587

  • 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.

    PubMed 21467183

  • 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.

    PubMed 32429728

  • 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.

    PubMed 31713752

Questions about this trial

What is this clinical trial studying?

An observational study of Retinitis Pigmentosa, run by Okuvision GmbH at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual field (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04983914, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.

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