Pilot Study of a Suprachoroidal Retinal Prosthesis

Sponsor

Center for Eye Research Australia (Other)

Overall Status

Completed

CT.gov ID

NCT01603576

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

1.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Retinitis Pigmentosa Choroideremia	Device: Prototype wide view suprachoroidal retinal prosthesis	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Feasibility Study of a Prototype Suprachoroidal Retinal Prosthesis for Vision Restoration

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Suprachoroidal retinal prosthesis	Device: Prototype wide view suprachoroidal retinal prosthesis Manufacturer = Bionics Institute, Australia

Arm

Intervention/Treatment

Experimental: Suprachoroidal retinal prosthesis

Device: Prototype wide view suprachoroidal retinal prosthesis

Manufacturer = Bionics Institute, Australia

Outcome Measures

Primary Outcome Measures

Safety [18 months]
Number of device-related serious adverse events

Secondary Outcome Measures

Ability to perceive visual percepts during device stimulation [18 months]
Number of participants able to perceive phosphenes when the device is stimulated

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nicta / Data61	Canberra	Australian Capital Territory	Australia	2601
2	Centre for Eye Research Australia	East Melbourne	Victoria	Australia	3002

Sponsors and Collaborators

Center for Eye Research Australia

Investigators

Study Director: Anthony Burkitt, PhD, Bionic Vision Australia
Principal Investigator: Robyn Guymer, MBBS, PhD, Centre for Eye Research Australia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Center for Eye Research Australia

ClinicalTrials.gov Identifier:

NCT01603576

Other Study ID Numbers:

BVA_0001
090/2012

First Posted:

May 22, 2012

Last Update Posted:

Nov 16, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Retinitis

Retinitis Pigmentosa

Choroideremia

Study Results

No Results Posted as of Nov 16, 2016