ClinicalTrials.gg
Enrolling by invitationNCT05158049Updated Aug 23, 2024

Longitudinal Study of a Bionic Eye

An observational study in Retinitis Pigmentosa and Choroideremia, sponsored by Center for Eye Research Australia. Enrolling by invitation at 1 site in Australia. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by Center for Eye Research Australia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7
Sex
All
01

Study summary

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.

02

Conditions studied

  • Retinitis Pigmentosa
  • Choroideremia
03

In context

Retinitis Pigmentosa

278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.

This study's planned enrollment of 7 is below the median of 52 across 87 observational studies indexed under Retinitis Pigmentosa.

Browse Retinitis Pigmentosa studies →

Lead sponsor

Center for Eye Research Australia is the lead sponsor of 12 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Participants who were implanted with a suprachoroidal retinal prosthesis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Willing to provide signed ;
  • 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Effectiveness of vision processing method in the laboratory.

    Measure effectiveness of of the vision processing method via observational and quantitative data.

    Time frame: 5 years.

  2. 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.

    Time frame: 5 years.

Secondary outcomes

  1. Device stability and functionality.

    Monitor device stability with routine ophthalmic imaging, impedance and threshold testing.

    Time frame: 5 years.

  2. Participant experience.

    Document participant anecdotal experience with the VP method in 'real world' environments.

    Time frame: 5 years

  3. 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.

    Time frame: 5 years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — There is not a plan to make IPD available.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2021 (actual). Primary completion is estimated for Dec 2026, 60 months after the start.

Of 48 observational studies under Retinitis Pigmentosa, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 28. This study's planned 60 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2021
First posted
Dec 15, 2021
StartActual
Dec 9, 2021
Primary completionEst.
Dec 9, 2026
CompletionEst.
Dec 9, 2026
Last update
Aug 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05158049
Lead sponsor
Center for Eye Research Australia
Collaborators
The Bionics Institute of Australia, Australian National University, Commonwealth Scientific and Industrial Research Organisation, Australia, Bionic Vision Technologies
Responsible party
Sponsor
First posted
Dec 15, 2021
Start date
Dec 9, 2021
Primary completion
Dec 9, 2026 (estimated)
Completion
Dec 9, 2026 (estimated)
Last update
Aug 23, 2024

Study contacts

Penelope J Allen, FRACO, FRACS
principal investigator · Center for Eye Research Australia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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