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Pilot Study of a Suprachoroidal Retinal Prosthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01603576
Recruitment Status : Completed
First Posted : May 22, 2012
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Center for Eye Research Australia

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arms and Interventions
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Arm Intervention/treatment
Experimental: Suprachoroidal retinal prosthesis Device: Prototype wide view suprachoroidal retinal prosthesis
Manufacturer = Bionics Institute, Australia


Outcome Measures
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Primary Outcome Measures :
  1. Safety [ Time Frame: 18 months ]
    Number of device-related serious adverse events


Secondary Outcome Measures :
  1. Ability to perceive visual percepts during device stimulation [ Time Frame: 18 months ]
    Number of participants able to perceive phosphenes when the device is stimulated


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603576


Locations
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Australia, Australian Capital Territory
Nicta / Data61
Canberra, Australian Capital Territory, Australia, 2601
Australia, Victoria
Centre for Eye Research Australia
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Center for Eye Research Australia
Investigators
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Study Director: Anthony Burkitt, PhD Bionic Vision Australia
Principal Investigator: Robyn Guymer, MBBS, PhD Centre for Eye Research Australia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Center for Eye Research Australia
ClinicalTrials.gov Identifier: NCT01603576    
Other Study ID Numbers: BVA_0001
090/2012 ( Registry Identifier: Therapeutics Goods Administration, Australia )
First Posted: May 22, 2012    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Choroideremia
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
 Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Choroid Diseases
Uveal Diseases
Genetic Diseases, X-Linked