Pilot Study of a Suprachoroidal Retinal Prosthesis

Not Applicable

Completed

• Conditions: Retinitis Pigmentosa; Choroideremia
• Interventions: Device: Prototype wide view suprachoroidal retinal prosthesis

• Registration Number: NCT01603576
• Lead Sponsor: Center for Eye Research Australia

Brief Summary

This study will be an initial proof of concept study, to evaluate safety and efficacy of a prototype suprachoroidal retinal implant

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-18
• Study First Submitted QC: 2012-05-19
• Study First Posted: 2012-05-22
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Suprachoroidal retinal prosthesis	Prototype wide view suprachoroidal retinal prosthesis	-

Primary Outcome Measures

Name	Time	Method
Safety	18 months	Number of device-related serious adverse events

Secondary Outcome Measures

Name	Time	Method
Ability to perceive visual percepts during device stimulation	18 months	Number of participants able to perceive phosphenes when the device is stimulated

Trial Locations

Locations (2)

Centre for Eye Research Australia; 🇦🇺 East Melbourne, Victoria, Australia

Nicta / Data61; 🇦🇺 Canberra, Australian Capital Territory, Australia