Retinitis Pigmentosa (RP)TES-STEPNCT07548944
Observational Study to Investigate the Short-term Effects of Transcorneal Electrical Stimulation on Visual Performance
An observational study of Retinitis Pigmentosa (RP) and Usher Syndrome, run by Okuvision GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa (RP), Usher Syndrome, Cone Rod Dystrophy
- What is being tested?
- Transcorneal Electrical Stimulation using the OkuStim System
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 20 Apr 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Augenzentrum Frankfurt Prof. Koch GmbH
Frankfurt am Main, 60549
Claudia Büdel, +49 69 7566 8880, info@azffm.de
Dr. med. Svenja Deuchler
About this study
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
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.
Read the 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.
- Being tested
- Transcorneal Electrical Stimulation using the OkuStim System
- Keywords
- Transcorneal Electrical Stimulation, TES, OkuStim, Okuvision, Retinitis pigmentosa, Eye Diseases, Retinal Dystrophies, Retinal Degeneration, Retinal Diseases
- Medical subject headings
- Retinitis Pigmentosa, Usher Syndromes, Cone-Rod Dystrophies, Eye Diseases, Retinal Dystrophies, Retinal Degeneration, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcorneal Electrical Stimulation using the OkuStim SystemDevice
Also called OkuStim
Single application of the OkuStim® System for TES therapy in accordance with its intended purpose for 30 minutes.
No control or comparative intervention planned.
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity
Measured with ETDRS chart and Manifold Platform
Measured: - 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
Measured: Baseline, immediately after TES, and approx. 3.5 hours after TES
Retinal sensitivity
Measured with microperimetry
Measured: Baseline and approx. 3.5 hours after TES
Subjective changes in visual performance
Questionnaire on perceived changes in visual performance after TES therapy
Measured: Approx. 3.5 hours after TES
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start20 Apr 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis Pigmentosa (RP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okuvision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. med. Svenja Deuchler, Principal investigator, Augenzentrum Frankfurt Prof. Koch GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548944
- Sponsor's protocol ID
- TES-STEP
- Acronym
- TES-STEP
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07548944
- Acronym / sponsor ID
- TES-STEP / TES-STEP
- Keywords
- Transcorneal Electrical Stimulation, TES, OkuStim, Okuvision, Retinitis pigmentosa, Eye Diseases, Retinal Dystrophies, Retinal Degeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Okuvision GmbHIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcorneal Electrical Stimulation using the OkuStim SystemAlso: OkuStimSingle application of the OkuStim® System for TES therapy in accordance with its intended purpose for 30 minutes. No control or comparative intervention planned. | Device | – |
Primary outcome
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
Contrast sensitivity
Time frame: Baseline, immediately after TES, and approx. 3.5 hours after TES
Quick contrast sensitivity function (qCSF) measured with Manifold Platform
Retinal sensitivity
Time frame: Baseline and approx. 3.5 hours after TES
Measured with microperimetry
Subjective changes in visual performance
Time frame: Approx. 3.5 hours after TES
Questionnaire on perceived changes in visual performance after TES therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. med. Svenja Deuchler principal investigator
Augenzentrum Frankfurt Prof. Koch GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa (RP) and Usher Syndrome, run by Okuvision GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Büdel (+49 69 7566 8880, info@azffm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.