- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05158049
Longitudinal Study of a Bionic Eye
March 24, 2023 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 (Anticipated)
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
-
-
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
Genders Eligible for Study
All
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.
Collaborators
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.
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 (Anticipated)
December 9, 2026
Study Completion (Anticipated)
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)
March 27, 2023
Last Update Submitted That Met QC Criteria
March 24, 2023
Last Verified
March 1, 2023
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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