Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bionic Vision Technologies | UNKNOWN |
| Center for Eye Research Australia | OTHER |
| The Bionics Institute of Australia | OTHER |
| University of Melbourne |
Not provided
Not provided
Not provided
Not provided
This study is a proof of principal, to evaluate a safety and efficacy of a prototype suprachoroidal retinal implant.
Retinal visual prostheses are currently in early development as an intervention to improve functional vision in people who have become blind from retinal degenerative eye disease. This study follows on from an initial proof of concept study (n=3) between 2012 and 2014, and will test a second-generation retinal prosthesis device, which has the ability to be used outside of the laboratory environment (i.e. is fully implantable).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suprachoroidal retinal prosthesis | Experimental | Prototype wide view suprachoroidal retinal prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 44Ch Bionic Eye Device | Device | Prototype wide view suprachoroidal retinal prosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of device related serious adverse events (SAEs) | The safety of the surgical implantation assessed by the number and severity of serious adverse events (SAEs) compared to other retinal prosthesis. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - visual response | The ability to generate a visual response accessed via repeatable threshold measurements of visual perception. | 2 years |
| Visual Function and Functional Vision | Visual function and Functional Vision will be scored from performance on a range of acuity, orientation and mobility, and activities of daily living tasks. Outcome measures include:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Penelope Allen, FRACO, FRACS | Center for Eye Research Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Eye Research Australia | Melbourne | Victoria | 3002 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25521292 | Background | 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. | |
| 36066322 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D015794 | Choroideremia |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
Not provided
Not provided
| OTHER |
| Data 61 CSIRO | UNKNOWN |
| Australian National University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 years |
| Quality of life - IVI - very low vision validated questionnaire | Quality of life will be assessed via survey and self-report. The Functional Low Vision Observer Assessment (FLORA) is a questionnaire that will be used to measure participants changes in participant daily living experiences. | 2 years |
| Derived |
| Abbott CJ, Baglin EK, Kolic M, McGuinness MB, Titchener SA, Young KA, Yeoh J, Luu CD, Ayton LN, Petoe MA, Allen PJ. Interobserver Agreement of Electrode to Retina Distance Measurements in a Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis. Transl Vis Sci Technol. 2022 Sep 1;11(9):4. doi: 10.1167/tvst.11.9.4. |
| 35696133 | Derived | Titchener SA, Nayagam DAX, Kvansakul J, Kolic M, Baglin EK, Abbott CJ, McGuinness MB, Ayton LN, Luu CD, Greenstein S, Kentler WG, Shivdasani MN, Allen PJ, Petoe MA. A Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis: Long-Term Observation of the Electrode-Tissue Interface. Transl Vis Sci Technol. 2022 Jun 1;11(6):12. doi: 10.1167/tvst.11.6.12. |
| 34581770 | Derived | Petoe MA, Titchener SA, Kolic M, Kentler WG, Abbott CJ, Nayagam DAX, Baglin EK, Kvansakul J, Barnes N, Walker JG, Epp SB, Young KA, Ayton LN, Luu CD, Allen PJ; Bionics Institute and Centre for Eye Research Australia Retinal Prosthesis Consortium. A Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis: Interim Clinical Trial Results. Transl Vis Sci Technol. 2021 Aug 12;10(10):12. doi: 10.1167/tvst.10.10.12. |
| 34383875 | Derived | Karapanos L, Abbott CJ, Ayton LN, Kolic M, McGuinness MB, Baglin EK, Titchener SA, Kvansakul J, Johnson D, Kentler WG, Barnes N, Nayagam DAX, Allen PJ, Petoe MA. Functional Vision in the Real-World Environment With a Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis. Transl Vis Sci Technol. 2021 Aug 12;10(10):7. doi: 10.1167/tvst.10.10.7. |
| 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 |