Menu
Recruiting NCT07548944

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

— Observational Retinitis Pigmentosa (RP) Usher Syndrome Cone Rod Dystrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcorneal Electrical Stimulation using the OkuStim System.
Who it may be relevant to
Registry conditions: Retinitis Pigmentosa (RP), Usher Syndrome, Cone Rod Dystrophy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Device Transcorneal Electrical Stimulation using the OkuStim System
    Single application of the OkuStim® System for TES therapy in accordance with its intended purpose for 30 minutes. No control or comparative intervention planned.

Primary outcome measures

  • 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]
  • Contrast sensitivity [Time frame: Baseline, immediately after TES, and approx. 3.5 hours after TES]
  • Retinal sensitivity [Time frame: Baseline and approx. 3.5 hours after TES]
  • Subjective changes in visual performance [Time frame: Approx. 3.5 hours after TES]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Germany · 1 center
  • Augenzentrum Frankfurt Prof. Koch GmbH — Frankfurt am Main

Identifiers

NCT: NCT07548944 · TES-STEP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗