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| ID | Type | Description | Link |
|---|---|---|---|
| Retina Implant Project |
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The outcome of this trial will reveal the possibilities of the retinal implant to improve the situation of patients with hereditary retinal blindness caused by degenerations of the outer retina. This pilot study will give important information on safety and efficacy of sub-retinal implants.
Although the design of the chip with a possible resolution of up to 1500 image points has the potential of providing object recognition, the quality of the image transmitted in this first human application cannot be foreseen. On the other hand clinical experience teaches us that even bare light recognition improves mobility of patients because of the ability to localize bright light sources such as windows or lamps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1, 2 | Experimental | During measurement/test periods, investigator sets implant into ON or OFF condition without subjects knowledge of when device is active. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retina implant is surgically placed into subretinal position | Device | Subretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation & mobility. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity / Light-perception / Object-orientation are significantly improved with implant-ON versus OFF as shown via FrACT / BaLM / grating test (i.e. EFFICACY) | within implantation period | |
| Patient treatment shows acceptable results (i.e. SAFETY) | within implantation period |
| Measure | Description | Time Frame |
|---|---|---|
| Activities of Daily Living are significantly improved with implant-ON versus OFF, as shown via Tasks of Daily Living test / Orientation & Mobility test (i.e. EFFICACY) | within implantation period | |
| Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eberhart - Zrenner, Prof.Dr.med. | University Eye Hospital Tuebingen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Hospital Dresden-Friedrichstadt | Dresden | 01067 | Germany | |||
| University Eye Hospital Tuebingen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24150759 | Derived | Stingl K, Bartz-Schmidt KU, Gekeler F, Kusnyerik A, Sachs H, Zrenner E. Functional outcome in subretinal electronic implants depends on foveal eccentricity. Invest Ophthalmol Vis Sci. 2013 Nov 19;54(12):7658-65. doi: 10.1167/iovs.13-12835. | |
| 22562517 | Derived | Kusnyerik A, Greppmaier U, Wilke R, Gekeler F, Wilhelm B, Sachs HG, Bartz-Schmidt KU, Klose U, Stingl K, Resch MD, Hekmat A, Bruckmann A, Karacs K, Nemeth J, Suveges I, Zrenner E. Positioning of electronic subretinal implants in blind retinitis pigmentosa patients through multimodal assessment of retinal structures. Invest Ophthalmol Vis Sci. 2012 Jun 20;53(7):3748-55. doi: 10.1167/iovs.11-9409. |
| Label | URL |
|---|---|
| patient self-help, support and advocacy organization | View source |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D001766 | Blindness |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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|
| within implantation period |
| Tübingen |
| 72076 |
| Germany |
| 21693599 | Derived | Wilke R, Gabel VP, Sachs H, Bartz Schmidt KU, Gekeler F, Besch D, Szurman P, Stett A, Wilhelm B, Peters T, Harscher A, Greppmaier U, Kibbel S, Benav H, Bruckmann A, Stingl K, Kusnyerik A, Zrenner E. Spatial resolution and perception of patterns mediated by a subretinal 16-electrode array in patients blinded by hereditary retinal dystrophies. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5995-6003. doi: 10.1167/iovs.10-6946. |
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |