Study of a Suprachoroidal Retinal Prosthesis

Mobius Medical

Status

Completed

Conditions

Choroideremia

Retinitis Pigmentosa

Treatments

Device: 44Ch Bionic Eye Device

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03406416

BVT_001

Details and patient eligibility

About

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

Full 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 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).

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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