Choroideremia, Retinitis Pigmentosa
Conditions
Brief summary
This study will be an initial proof of concept study, to evaluate safety and efficacy of a prototype suprachoroidal retinal implant
Interventions
DEVICEPrototype wide view suprachoroidal retinal prosthesis
Manufacturer = Bionics Institute, Australia
Sponsors
Center for Eye Research Australia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Either gender * A confirmed history of outer retinal degenerative disease such as retinitis pigmentosa or choroideremia * Remaining visual acuity of bare light perception or less in both eyes * Functional inner retina (ganglion cells and optic nerve), as shown by the ability to perceive light and/or a measurable corneal electrically evoked visual response * A history of at least 10 years of useful form vision in the worse seeing eye * Must be willing and able to comply with the testing and follow-up protocol demands (preferably residing within 1.5 hours of the investigational site)
Exclusion criteria
* Optic nerve disease (history of glaucoma of more than 1 month, or history of any other optic neuropathy) * Diseases of the inner retina including, but not limited to, central retinal artery or vein occlusion (CRAO, CRVO), end stage diabetic retinopathy, retinal detachment, traumatic retinal damage, infectious retinal disease, inflammatory retinal disease. * Inability to visualise the retina due to corneal or other ocular media opacities (corneal degenerations, dense cataracts, trauma, lid malpositions) * Any ocular condition that predisposes the subject to rubbing their eyes * Cognitive deficiencies, including dementia or progressive neurological disease * Psychiatric disorders, including depression, as diagnosed by a qualified psychologist * Deafness or significant hearing loss * Inability to speak or understand English * Pregnancy * Presence of a cochlear implant * Subject enrolled in another investigational drug or device trial for the treatment of their ocular condition * Poor general health, which would exclude them from obtaining a general anaesthetic * Unrealistic expectations of the bionic eye device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 18 months | Number of device-related serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability to perceive visual percepts during device stimulation | 18 months | Number of participants able to perceive phosphenes when the device is stimulated |
Countries
Australia
Outcome results
None listed