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

NCT07548944 | Recruiting

• 1 other identifier: TES-STEP
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retinitis Pigmentosa (RP); Usher Syndrome; Cone Rod Dystrophy

Keywords

Transcorneal Electrical Stimulation; TES; OkuStim; Okuvision; Retinitis pigmentosa; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases

Outcome Measures

Primary Outcomes (4)

• Best-corrected visual acuity

  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

  Quick contrast sensitivity function (qCSF) measured with Manifold Platform

  Baseline, immediately after TES, and approx. 3.5 hours after TES

• Retinal sensitivity

  Measured with microperimetry

  Baseline and approx. 3.5 hours after TES

• Subjective changes in visual performance

  Questionnaire on perceived changes in visual performance after TES therapy

  Approx. 3.5 hours after TES

Other Outcomes (1)

• Safety

  3.5 hours after TES

Interventions

Transcorneal Electrical Stimulation using the OkuStim System DEVICE

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

Also known as: OkuStim

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Okuvision GmbH: lead

Study Sites (1)

Augenzentrum Frankfurt Prof. Koch GmbH

Frankfurt am Main, 60549, Germany

RECRUITING

MeSH Terms

Conditions

Retinitis Pigmentosa; Usher Syndromes; Cone-Rod Dystrophies; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Deaf-Blind Disorders; Deafness; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Hearing Loss, Sensorineural; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Vision Disorders; Abnormalities, Multiple; Congenital Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. med. Svenja Deuchler

  Augenzentrum Frankfurt Prof. Koch GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Büdel

CONTACT

+49 69 7566 8880; info@azffm.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 23, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)