Overview

This trial has been completed.

Conditions retinitis pigmentosa, choroideremia
Treatment prototype wide view suprachoroidal retinal prosthesis
Sponsor Center for Eye Research Australia
Start date May 2012
End date August 2014
Trial size 3 participants
Trial identifier NCT01603576, 090/2012, BVA_0001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
prototype wide view suprachoroidal retinal prosthesis
Manufacturer = Bionics Institute, Australia

Primary Outcomes

Measure
Safety
time frame: 18 months

Secondary Outcomes

Measure
Ability to perceive visual percepts during device stimulation
time frame: 18 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Safety and Feasibility Study of a Prototype Suprachoroidal Retinal Prosthesis for Vision Restoration
Principal investigator Robyn Guymer, MBBS, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Center for Eye Research Australia.