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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05158049




Registration number
NCT05158049
Ethics application status
Date submitted
2/12/2021
Date registered
15/12/2021

Titles & IDs
Public title
Longitudinal Study of a Bionic Eye
Scientific title
Longitudinal Observation and Assessment of the Suprachoroidal Retinal Prostheses
Secondary ID [1] 0 0
75829
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinitis Pigmentosa 0 0
Choroideremia 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effectiveness of vision processing method in the laboratory.
Timepoint [1] 0 0
5 years.
Primary outcome [2] 0 0
Effectiveness of vision processing method in the 'real world' featured environment.
Timepoint [2] 0 0
5 years.
Secondary outcome [1] 0 0
Device stability and functionality.
Timepoint [1] 0 0
5 years.
Secondary outcome [2] 0 0
Participant experience.
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Participant interview.
Timepoint [3] 0 0
5 years

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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/12/2026
Actual
Sample size
Target
7
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Centre for Eye Research Australia - Melbourne E.
Recruitment postcode(s) [1] 0 0
3002 - Melbourne E.

Funding & Sponsors
Primary sponsor type
Other
Name
Center for Eye Research Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Bionics Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian National University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Commonwealth Scientific and Industrial Research Organisation, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Bionic Vision Technologies
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Penelope J Allen, FRACO, FRACS
Address 0 0
Centre for Eye Research Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is not a plan to make IPD available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05158049