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Pilot Study of a Suprachoroidal Retinal Prosthesis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Center for Eye Research Australia
ClinicalTrials.gov Identifier:
NCT01603576
First received: May 18, 2012
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Retinitis Pigmentosa
Choroideremia
 Device: Prototype wide view suprachoroidal retinal prosthesis

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Feasibility Study of a Prototype Suprachoroidal Retinal Prosthesis for Vision Restoration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Center for Eye Research Australia:

Primary Outcome Measures:
  • Safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Number of device-related serious adverse events


Secondary Outcome Measures:
  • Ability to perceive visual percepts during device stimulation [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Number of participants able to perceive phosphenes when the device is stimulated


Estimated Enrollment: 10
Study Start Date: May 2012
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Suprachoroidal retinal prosthesis Device: Prototype wide view suprachoroidal retinal prosthesis
Manufacturer = Bionics Institute, Australia

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603576

Locations
Australia, Victoria
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
  More Information

No publications provided

Responsible Party: Center for Eye Research Australia
ClinicalTrials.gov Identifier: NCT01603576     History of Changes
Other Study ID Numbers: BVA_0001, 090/2012
Study First Received: May 18, 2012
Last Updated: February 12, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Choroideremia
Retinitis
Retinitis Pigmentosa
Eye Diseases, Hereditary
Eye Diseases
Choroid Diseases
 Uveal Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Retinal Diseases
Retinal Dystrophies
Retinal Degeneration

ClinicalTrials.gov processed this record on May 23, 2013