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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety | Number and nature of device-related adverse events and serious adverse events | 3.5 hours after TES |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Büdel | Contact | +49 69 7566 8880 | info@azffm.de |
| Name | Affiliation | Role |
|---|---|---|
| Dr. med. Svenja Deuchler | Augenzentrum Frankfurt Prof. Koch GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augenzentrum Frankfurt Prof. Koch GmbH | Recruiting | Frankfurt am Main | 60549 | Germany |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D052245 | Usher Syndromes |
| D000071700 | Cone-Rod Dystrophies |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D054062 | Deaf-Blind Disorders |
| D003638 | Deafness |
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006319 | Hearing Loss, Sensorineural |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001766 | Blindness |
| D014786 | Vision Disorders |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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