Status:
COMPLETED
Study of a Suprachoroidal Retinal Prosthesis
Lead Sponsor:
Mobius Medical Pty Ltd.
Collaborating Sponsors:
Bionic Vision Technologies
Center for Eye Research Australia
Conditions:
Retinitis Pigmentosa
Choroideremia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a proof of principal, to evaluate a safety and efficacy of a prototype suprachoroidal retinal implant.
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03406416
Start Date
February 13 2018
End Date
December 18 2020
Last Update
August 16 2021
Active Locations (1)
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1
Centre for Eye Research Australia
Melbourne, Victoria, Australia, 3002