Skip to main content
OpenTrials
Completed

NCT Number: NCT01603576

Pilot Study of a Suprachoroidal Retinal Prosthesis

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nicta / Data61, Canberra, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prototype wide view suprachoroidal retinal prosthesis

Device

Manufacturer = Bionics Institute, Australia

Primary outcomes

  1. Safety

    Time frame: 18 months

    Number of device-related serious adverse events

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Center for Eye Research Australia

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 22, 2012
Registry last updated
Nov 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.