Observational Study to Investigate the Short-term Effects of Transcorneal Electrical Stimulation on Visual Performance (TES-STEP)

April 30, 2026 updated by: Okuvision GmbH

Observational Study to Investigate the Short-term Effects of Transcorneal Electrical Stimulation (TES) on Visual Performance in Patients With Retinitis Pigmentosa and Similar Retinal Diseases

Retinitis pigmentosa and similar degenerative diseases of the retina lead to progressive loss of vision. TES therapy with the CE-marked OkuStim® System is a treatment approved in the EU for slowing the progression of the disease. Patients increasingly report short-term subjective improvements in vision, which have not yet been systematically investigated. This exploratory study is conducted to determine whether these subjective short-term effects can be measured, and therefore also be quantified, by objective tests.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This open-label observational study includes patients with retinitis pigmentosa or similar degenerative diseases (e.g. Usher syndrome, cone rod dystrophy) who already use the OkuStim System and are experiencing short-term effects following treatment.

Study procedure:

Participants will complete a questionnaire on previous experiences with short-term effects following transcorneal electrical stimulation therapy with the OkuStim System. If eligible, baseline ophthalmologic examinations will be performed, including slit-lamp examination, best-corrected visual acuity (BCVA), quick contrast sensitivity function (qCSF), kinetic perimetry, and microperimetry. Participants will then receive TES treatment with the OkuStim System according to the prescribed stimulation parameters for 30 minutes. Following treatment, examinations on BCVA and qCSF will be repeated. After a break of approx. 3.5 hours, participants will complete a second questionnaire assessing currently perceived changes in visual performance. Final examinations will be performed, including BCVA, qCSF, and microperimetry.

This scientific study aims to contribute to a better understanding of the underlying mechanisms of TES.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

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

Study Contact

  • Name: Claudia Büdel
  • Phone Number: +49 69 7566 8880
  • Email: info@azffm.de

Study Locations

  • Germany
      • Frankfurt am Main, Germany, 60549
        • Recruiting
        • Augenzentrum Frankfurt Prof. Koch GmbH
        • Contact:
          • Claudia Büdel
          • Phone Number: +49 69 7566 8880
          • Email: info@azffm.de
        • Principal Investigator:
          • Dr. med. Svenja Deuchler

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with retinitis pigmentosa or other similar degenerative retinal disease recruited through Augenzentrum Frankfurt Prof. Koch GmbH, including both existing patients and individuals responding to a public study announcement.

Description

Inclusion Criteria:

  • Adult patients (≥ 18 years) with clinically diagnosed retinitis pigmentosa (RP) or other similar degenerative retinal disease
  • Current treatment with TES using the OkuStim® System within the intended purpose
  • Subjective perception of short-term effects after TES treatment
  • Ability and willingness to give informed consent

Exclusion Criteria:

  • Cognitive, psychological, or linguistic limitations that prevent informed consent or proper study participation
  • Presence of other eye diseases (e.g., cataract, glaucoma, macular degeneration) that, in the opinion of the investigator, compromise or confound study assessments
  • Simultaneous participation in other clinical studies that could influence the results of the study
  • Severe comorbidities that could compromise patient safety or study conduct

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
Best-corrected visual acuity
Time Frame: - ETDRS: Baseline and approx. 3.5 hours after TES - Manifold Platform: Baseline, immediately after TES, and approx. 3.5 hours after TES
Measured with ETDRS chart and Manifold Platform
- ETDRS: Baseline and approx. 3.5 hours after TES - Manifold Platform: Baseline, immediately after TES, and approx. 3.5 hours after TES
Contrast sensitivity
Time Frame: Baseline, immediately after TES, and approx. 3.5 hours after TES
Quick contrast sensitivity function (qCSF) measured with Manifold Platform
Baseline, immediately after TES, and approx. 3.5 hours after TES
Retinal sensitivity
Time Frame: Baseline and approx. 3.5 hours after TES
Measured with microperimetry
Baseline and approx. 3.5 hours after TES
Subjective changes in visual performance
Time Frame: Approx. 3.5 hours after TES
Questionnaire on perceived changes in visual performance after TES therapy
Approx. 3.5 hours after TES

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 3.5 hours after TES
Number and nature of device-related adverse events and serious adverse events
3.5 hours after TES

Collaborators and Investigators

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

Sponsor

Okuvision GmbH

Investigators

  • Principal Investigator: Dr. med. Svenja Deuchler, Augenzentrum Frankfurt Prof. Koch GmbH

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)

April 20, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TES-STEP

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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