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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

Tracking Information
First Submitted Date  ICMJE May 18, 2012
First Posted Date  ICMJE May 22, 2012
Last Update Posted Date November 16, 2016
Study Start Date  ICMJE May 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2012)
Safety [ Time Frame: 18 months ]
Number of device-related serious adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2012)
Ability to perceive visual percepts during device stimulation [ Time Frame: 18 months ]
Number of participants able to perceive phosphenes when the device is stimulated
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of a Suprachoroidal Retinal Prosthesis
Official Title  ICMJE Safety and Feasibility Study of a Prototype Suprachoroidal Retinal Prosthesis for Vision Restoration
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Retinitis Pigmentosa
  • Choroideremia
Intervention  ICMJE Device: Prototype wide view suprachoroidal retinal prosthesis
Manufacturer = Bionics Institute, Australia
Study Arms  ICMJE Experimental: Suprachoroidal retinal prosthesis
Intervention: Device: Prototype wide view suprachoroidal retinal prosthesis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2014)
3
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2012)
10
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01603576
Other Study ID Numbers  ICMJE BVA_0001
090/2012 ( Registry Identifier: Therapeutics Goods Administration, Australia )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Center for Eye Research Australia
Study Sponsor  ICMJE Center for Eye Research Australia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anthony Burkitt, PhD Bionic Vision Australia
Principal Investigator: Robyn Guymer, MBBS, PhD Centre for Eye Research Australia
PRS Account Center for Eye Research Australia
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP