Retrospective NIS to Evaluate the Patient Benefit of TES

August 19, 2022 updated by: Okuvision GmbH

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg, Augenklinik
      • Stuttgart, Germany, 70174
        • Klinikum Stuttgart gKAöR, Augenklinik Standort Mitte (Katharinenhospital)
      • Tübingen, Germany, 72076
        • Universitäts-Augenklinik Tübingen, Abt. für Augenheilkunde
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitätsspital Basel, Augenklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Not willing and able to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best-corrected visual acuity
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.
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.
Central foveal thickness
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.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reasons for discontinuation of therapy and patient satisfaction
Time Frame: 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
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
Adverse events
Time Frame: 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 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okuvision GmbH

Collaborators

CONET GmbH - Clinical Operations Network

Investigators

  • Principal Investigator: Hendrik Scholl, Prof. Dr., Department of Ophthalmology, University of Basel, Switzerland
  • Principal Investigator: Katarina Stingl, Prof. Dr., University Eye Hospital Tuebingen, Tuebingen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2021

Primary Completion (Actual)

August 19, 2022

Study Completion (Actual)

August 19, 2022

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TES-NIS2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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