Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT05158049

Longitudinal Study of a Bionic Eye

This is a longitudinal observational study with participants who have been implanted with the suprachoroidal retinal prosthesis.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Retinitis Pigmentosa Choroid Diseases Choroideremia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Genetic Diseases, X-Linked Retinal Degeneration Retinal Diseases Retinal Dystrophies Uveal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Eye Research Australia

Melbourne E., Victoria, 3002, Australia

About this study

To observe and assess visual, orientation and mobility behavior with primary and adjunct vision processing (AVP) methods that may enhance the performance with the suprachoroidal retinal prosthesis (ScRP). To investigate the effectiveness of primary and AVP methods in the laboratory and real-world environments with the ScRP. Assess structural and functional ScRP stability with objective and subjective assessments. Record participant experiences and feedback with the ScRP.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Willing to provide signed informed consent;
  • Implanted with a suprachoroidal retinal prosthesis;
  • Be available for the study visits;
  • Willing to comply with study assessments;
  • In good general health and mobile.

Exclusion criteria

  • Medical condition that prohibits mobility;
  • Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Treatment and study plan

Primary outcomes

  1. Effectiveness of vision processing method in the laboratory.

    Time frame: 5 years.

    Measure effectiveness of of the vision processing method via observational and quantitative data.

  2. Effectiveness of vision processing method in the 'real world' featured environment.

    Time frame: 5 years.

    Measure the effectiveness of the vision processing method via observational qualitative and quantitative data in participant 'real world' featured environment.

Secondary outcomes

  1. Device stability and functionality.

    Time frame: 5 years.

    Monitor device stability with routine ophthalmic imaging, impedance and threshold testing.

  2. Participant experience.

    Time frame: 5 years

    Document participant anecdotal experience with the VP method in 'real world' environments.

  3. Participant interview.

    Time frame: 5 years

    Interview participants to capture participant experience with the ScRP, determine differences in functional outcomes and utilise this information to improve assessment of functional outcomes.

Sponsors and collaborators

Lead sponsor

Center for Eye Research Australia

Other

Collaborators

  • Australian National University
  • Bionic Vision Technologies
  • Commonwealth Scientific and Industrial Research Organisation, Australia
  • The Bionics Institute of Australia

Registry information

Official study title

Longitudinal Observation and Assessment of the Suprachoroidal Retinal Prostheses

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2021
Registry last updated
Aug 23, 2024

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.

Related clinical trials

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