Retinitis PigmentosaNCT05158049
Longitudinal Study of a Bionic Eye
An observational study of Retinitis Pigmentosa and Choroideremia, run by Center for Eye Research Australia at 1 site in Australia.
Trial summary
This is a longitudinal observational study with participants who have been implanted with the suprachoroidal retinal prosthesis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinitis Pigmentosa, Choroideremia
- How many people
- 7 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Dec 2021to 9 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who were implanted with a suprachoroidal retinal prosthesis.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Centre for Eye Research Australia
Melbourne E., Victoria, 3002
About this study
Official title: 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.
Read the 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.
- Conditions
- Retinitis Pigmentosa, Choroideremia
- Medical subject headings
- Retinitis Pigmentosa, Choroideremia
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of vision processing method in the laboratory.
Measure effectiveness of of the vision processing method via observational and quantitative data.
Measured: 5 years.
Effectiveness of vision processing method in the 'real world' featured environment.
Measure the effectiveness of the vision processing method via observational qualitative and quantitative data in participant 'real world' featured environment.
Measured: 5 years.
Secondary outcomes (3)
Device stability and functionality.
Monitor device stability with routine ophthalmic imaging, impedance and threshold testing.
Measured: 5 years.
Participant experience.
Document participant anecdotal experience with the VP method in 'real world' environments.
Measured: 5 years
Participant interview.
Interview participants to capture participant experience with the ScRP, determine differences in functional outcomes and utilise this information to improve assessment of functional outcomes.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start9 Dec 2021
- Primary completion9 Dec 2026 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Eye Research Australia
- Sponsor type
- University, hospital or other
- Collaborators
- The Bionics Institute of Australia, Australian National University, Commonwealth Scientific and Industrial Research Organisation, Australia, Bionic Vision Technologies
- Responsible party
- Sponsor
- Investigators
- Penelope J Allen, FRACO, FRACS, Principal investigator, Center for Eye Research Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158049
- Sponsor's protocol ID
- 75829
- Status last verified
- Aug 2024
- First submitted
- 2 Dec 2021
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Moussallem L, Lombardi L, McGuinness MB, Kolic M, Baglin EK, Jin R, Habili N, Kvansakul J, Titchener SA, Abbott CJ, Walker JG, Allen PJ, Petoe MA, Barnes N. Navigational outcomes with a depth-based vision processing algorithm in a second-generation suprachoroidal retinal prosthesis. J Neural Eng. 2025 Apr 24;22(2). doi: 10.1088/1741-2552/adc83a.
PubMed 40174607
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observation and Assessment of the Suprachoroidal Retinal Prostheses
- ClinicalTrials.gov ID
- NCT05158049
- Acronym / sponsor ID
- 75829
- Conditions
- Retinitis Pigmentosa, Choroideremia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Center for Eye Research AustraliaUniversity, hospital or other
- Collaborators
- The Bionics Institute of Australia, Australian National University, Commonwealth Scientific and Industrial Research Organisation, Australia, Bionic Vision Technologies
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 9 Dec 2026 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a longitudinal observational study with participants who have been implanted with the suprachoroidal retinal prosthesis.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who were implanted with a suprachoroidal retinal prosthesis.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
Device stability and functionality.
Time frame: 5 years.
Participant experience.
Time frame: 5 years
Participant interview.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 40174607Moussallem L, Lombardi L, McGuinness MB, Kolic M, Baglin EK, Jin R, Habili N, Kvansakul J, Titchener SA, Abbott CJ, Walker JG, Allen PJ, Petoe MA, Barnes N. Navigational outcomes with a depth-based vision processing algorithm in a second-generation suprachoroidal retinal prosthesis. J Neural Eng. 2025 Apr 24;22(2). doi: 10.1088/1741-2552/adc83a.
- Study of a Suprachoroidal Retinal ProsthesisLink provided by the sponsor.
- Pilot Study of a Suprachoroidal Retinal ProsthesisLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Penelope J Allen, FRACO, FRACS principal investigator
Center for Eye Research Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa and Choroideremia, run by Center for Eye Research Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of vision processing method in the laboratory. (time frame: 5 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05158049, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024; AzTrials last refreshed its copy on 27 Oct 2026.