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| ID | Type | Description | Link |
|---|---|---|---|
| 090/2012 | Registry Identifier | Therapeutics Goods Administration, Australia |
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This study will be an initial proof of concept study, to evaluate safety and efficacy of a prototype suprachoroidal retinal implant
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suprachoroidal retinal prosthesis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prototype wide view suprachoroidal retinal prosthesis | Device | Manufacturer = Bionics Institute, Australia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Number of device-related serious adverse events | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to perceive visual percepts during device stimulation | Number of participants able to perceive phosphenes when the device is stimulated | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Burkitt, PhD | Bionic Vision Australia | Study Director |
| Robyn Guymer, MBBS, PhD | Center for Eye Research Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nicta / Data61 | Canberra | Australian Capital Territory | 2601 | Australia | ||
| Centre for Eye Research Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28793152 | Derived | Shivdasani MN, Sinclair NC, Gillespie LN, Petoe MA, Titchener SA, Fallon JB, Perera T, Pardinas-Diaz D, Barnes NM, Blamey PJ; Bionic Vision Australia Consortium. Identification of Characters and Localization of Images Using Direct Multiple-Electrode Stimulation With a Suprachoroidal Retinal Prosthesis. Invest Ophthalmol Vis Sci. 2017 Aug 1;58(10):3962-3974. doi: 10.1167/iovs.16-21311. | |
| 28660276 |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D015794 | Choroideremia |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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| East Melbourne |
| Victoria |
| 3002 |
| Australia |
| Derived |
| Petoe MA, McCarthy CD, Shivdasani MN, Sinclair NC, Scott AF, Ayton LN, Barnes NM, Guymer RH, Allen PJ, Blamey PJ; Bionic Vision Australia Consortium. Determining the Contribution of Retinotopic Discrimination to Localization Performance With a Suprachoroidal Retinal Prosthesis. Invest Ophthalmol Vis Sci. 2017 Jun 1;58(7):3231-3239. doi: 10.1167/iovs.16-21041. |
| 27170910 | Derived | Slater KD, Sinclair NC, Nelson TS, Blamey PJ, McDermott HJ; Bionic Vision Australia Consortium. neuroBi: A Highly Configurable Neurostimulator for a Retinal Prosthesis and Other Applications. IEEE J Transl Eng Health Med. 2015 Jul 13;3:3800111. doi: 10.1109/JTEHM.2015.2455507. eCollection 2015. |
| 25521292 | Derived | Ayton LN, Blamey PJ, Guymer RH, Luu CD, Nayagam DA, Sinclair NC, Shivdasani MN, Yeoh J, McCombe MF, Briggs RJ, Opie NL, Villalobos J, Dimitrov PN, Varsamidis M, Petoe MA, McCarthy CD, Walker JG, Barnes N, Burkitt AN, Williams CE, Shepherd RK, Allen PJ; Bionic Vision Australia Research Consortium. First-in-human trial of a novel suprachoroidal retinal prosthesis. PLoS One. 2014 Dec 18;9(12):e115239. doi: 10.1371/journal.pone.0115239. eCollection 2014. |
| 25205858 | Derived | Shivdasani MN, Sinclair NC, Dimitrov PN, Varsamidis M, Ayton LN, Luu CD, Perera T, McDermott HJ, Blamey PJ; Bionic Vision Australia Consortium. Factors affecting perceptual thresholds in a suprachoroidal retinal prosthesis. Invest Ophthalmol Vis Sci. 2014 Sep 9;55(10):6467-81. doi: 10.1167/iovs.14-14396. |
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D040181 | Genetic Diseases, X-Linked |