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NCT Number: NCT07548944

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

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.

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Key information

Conditions

Retinitis Pigmentosa (RP) Abnormalities, Multiple Blindness Cone Rod Dystrophy Cone-Rod Dystrophies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deaf-Blind Disorders Deafness Ear Diseases Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Retinal Dystrophies Retinitis Pigmentosa Sensation Disorders Signs and Symptoms Usher Syndrome Usher Syndromes Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Augenzentrum Frankfurt Prof. Koch GmbH

Frankfurt am Main, 60549, Germany

Location status: Recruiting

Location contact

Claudia Büdel

CONTACT

[email protected]

+49 69 7566 8880

Dr. med. Svenja Deuchler

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: OkuStim

Primary outcomes

  1. 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

  2. Contrast sensitivity

    Time frame: Baseline, immediately after TES, and approx. 3.5 hours after TES

    Quick contrast sensitivity function (qCSF) measured with Manifold Platform

  3. Retinal sensitivity

    Time frame: Baseline and approx. 3.5 hours after TES

    Measured with microperimetry

  4. Subjective changes in visual performance

    Time frame: Approx. 3.5 hours after TES

    Questionnaire on perceived changes in visual performance after TES therapy

Other outcomes

  1. Safety

    Time frame: 3.5 hours after TES

    Number and nature of device-related adverse events and serious adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Büdel

CONTACT

[email protected]

+49 69 7566 8880

Sponsors and collaborators

Lead sponsor

Okuvision GmbH

Industry

Registry information

Official study 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

Acronym: TES-STEP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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