Longitudinal Study of a Bionic Eye

August 21, 2024 updated by: Center for Eye Research Australia

Longitudinal Observation and Assessment of the Suprachoroidal Retinal Prostheses

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

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne E., Victoria, Australia, 3002
        • Centre for Eye Research Australia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants who were implanted with a suprachoroidal retinal prosthesis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years.
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.
5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device stability and functionality.
Time Frame: 5 years.
Monitor device stability with routine ophthalmic imaging, impedance and threshold testing.
5 years.
Participant experience.
Time Frame: 5 years
Document participant anecdotal experience with the VP method in 'real world' environments.
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Eye Research Australia

Collaborators

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

Investigators

  • Principal Investigator: Penelope J Allen, FRACO, FRACS, Centre for Eye Research Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2021

Primary Completion (Estimated)

December 9, 2026

Study Completion (Estimated)

December 9, 2026

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 15, 2021

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 75829

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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