Study of a Suprachoroidal Retinal Prosthesis

Study Overview
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Brief Summary
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This study is a proof of principal, to evaluate a safety and efficacy of a prototype suprachoroidal retinal implant.

Detailed Description
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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).

Official Title
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Evaluation of a Suprachoroidal Retinal Prosthesis: A 44 Channel Fully Implantable Study

Conditions
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Retinitis Pigmentosa, Choroideremia

Intervention / Treatment
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* Device: 44Ch Bionic Eye Device


Participation Criteria
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Eligibility Criteria
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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 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 participant 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 Participant 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 investigational device to provide functional vision Poorly controlled diabetes Epilepsy Unsuitable level of regular nystagmus (which would prevent ocular images from being obtained) Anyone with medical devices (implanted or carried) that could cause serious health problems if compromised by electro-magnetic interference

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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>Prototype wide view suprachoroidal retinal prosthesis | Device: 44Ch Bionic Eye Device<br>* Prototype wide view suprachoroidal retinal prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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: Grating visual acuity: record the grating acuity level and average response time. Square localization: response error and response time is measured. Motion detection: response error and response time is measured. Table top task: locate and identify objects on a table. Accuracy rates and response times will be recorded. Doorway detection task: to find doorway target. Task time and accuracy of door touch will be recorded. Obstacle avoidance task: task time and number of collisions is recorded. Functional Low Vision Observer Rated Assessment (FLORA): this assessment tool Is used to evaluate participant functional vision and mobility. | 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 |