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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05158049
Registration number
NCT05158049
Ethics application status
Date submitted
2/12/2021
Date registered
15/12/2021
Date last updated
27/03/2023
Titles & IDs
Public title
Longitudinal Study of a Bionic Eye
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Scientific title
Longitudinal Observation and Assessment of the Suprachoroidal Retinal Prostheses
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Secondary ID [1]
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75829
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Retinitis Pigmentosa
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Choroideremia
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0
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Condition category
Condition code
Eye
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0
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Diseases / disorders of the eye
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Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Effectiveness of vision processing method in the laboratory.
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Assessment method [1]
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Measure effectiveness of of the vision processing method via observational and quantitative data.
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Timepoint [1]
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5 years.
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Primary outcome [2]
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Effectiveness of vision processing method in the 'real world' featured environment.
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Assessment method [2]
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Measure the effectiveness of the vision processing method via observational qualitative and quantitative data in participant 'real world' featured environment.
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Timepoint [2]
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5 years.
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Secondary outcome [1]
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Device stability and functionality.
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Assessment method [1]
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Monitor device stability with routine ophthalmic imaging, impedance and threshold testing.
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Timepoint [1]
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5 years.
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Secondary outcome [2]
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Participant experience.
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Assessment method [2]
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Document participant anecdotal experience with the VP method in 'real world' environments.
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Timepoint [2]
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5 years
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Secondary outcome [3]
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Participant interview.
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Assessment method [3]
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Interview participants to capture participant experience with the ScRP, determine differences in functional outcomes and utilise this information to improve assessment of functional outcomes.
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Timepoint [3]
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5 years
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Eligibility
Key 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.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/12/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
9/12/2026
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Actual
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Sample size
Target
7
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Centre for Eye Research Australia - Melbourne E.
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Recruitment postcode(s) [1]
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3002 - Melbourne E.
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Funding & Sponsors
Primary sponsor type
Other
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Name
Center for Eye Research Australia
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Bionics Institute
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Australian National University
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Commonwealth Scientific and Industrial Research Organisation, Australia
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Bionic Vision Technologies
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a longitudinal observational study with participants who have been implanted with the
suprachoroidal retinal prosthesis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05158049
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Penelope J Allen, FRACO, FRACS
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Address
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Centre for Eye Research Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05158049
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