Pilot Study of a Suprachoroidal Retinal Prosthesis

Study Overview
=================
Brief Summary
-----------------
This study will be an initial proof of concept study, to evaluate safety and efficacy of a prototype suprachoroidal retinal implant

Official Title
-----------------
Safety and Feasibility Study of a Prototype Suprachoroidal Retinal Prosthesis for Vision Restoration

Conditions
-----------------
Retinitis Pigmentosa, Choroideremia

Intervention / Treatment
-----------------
* Device: Prototype wide view suprachoroidal retinal prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suprachoroidal retinal prosthesis<br> | Device: Prototype wide view suprachoroidal retinal prosthesis<br>* Manufacturer = Bionics Institute, Australia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of device-related serious adverse events | 18 months | 

Secondary Outcome Measures

| Outcome Measure | 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 |