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| ID | Type | Description | Link |
|---|---|---|---|
| RI-MC-CT-2009 | Registry Identifier | Clinicaltrials.gov |
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Patients who are legally blind, caused by retinal degeneration of photoreceptor rods & cones (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intra-individual implant ON | Experimental | intra-individual implant activation |
|
| intra-individual implant OFF | Placebo Comparator | intra-individual implant deactivation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical implantation of subretinal device | Procedure | surgical implantation of subretinal device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | treatment shows no permanent damage of function and structures that have been functional before surgery and no permanent damage to health and/or well being of patients | 1 year |
| Efficacy | Activities of Daily Living & Mobility are significantly improved with implant-ON versus OFF, as shown via tests:
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Patient long term safety:
| 1 year |
| Efficacy | Visual Acuity / Light-perception and/or Object-recognition are significantly improved with implant-ON versus OFF as shown via:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Wong, Prof., MD | Chair Professor in Ophthalmology Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Eye Institute, University of Hong Kong | Hong Kong | Cyberport | 100 | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25812924 | Result | Stingl K, Bartz-Schmidt KU, Besch D, Chee CK, Cottriall CL, Gekeler F, Groppe M, Jackson TL, MacLaren RE, Koitschev A, Kusnyerik A, Neffendorf J, Nemeth J, Naeem MA, Peters T, Ramsden JD, Sachs H, Simpson A, Singh MS, Wilhelm B, Wong D, Zrenner E. Subretinal Visual Implant Alpha IMS--Clinical trial interim report. Vision Res. 2015 Jun;111(Pt B):149-60. doi: 10.1016/j.visres.2015.03.001. Epub 2015 Mar 23. |
| Label | URL |
|---|---|
| Hong Kong clinical trials registry | View source |
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| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012174 | Retinitis Pigmentosa |
| D001766 | Blindness |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D058499 | Retinal Dystrophies |
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| ID | Term |
|---|---|
| D012172 | Retinaldehyde |
| ID | Term |
|---|---|
| D000447 | Aldehydes |
| D009930 | Organic Chemicals |
| D012176 | Retinoids |
| D002338 | Carotenoids |
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| surgical implantation of subretinal device | Procedure | intra-individual implant OFF |
|
|
| 1 year |
| 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 |
| D011090 |
| Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |