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Longitudinal Study of a Bionic Eye

Longitudinal Observation and Assessment of the Suprachoroidal Retinal Prostheses

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05158049
Enrollment
7
Registered
2021-12-15
Start date
2021-12-09
Completion date
2026-12-09
Last updated
2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choroideremia, Retinitis Pigmentosa

Brief summary

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.

Interventions

None listed

Sponsors

The Bionics Institute of Australia
CollaboratorOTHER
Australian National University
CollaboratorOTHER
Commonwealth Scientific and Industrial Research Organisation, Australia
CollaboratorOTHER_GOV
Bionic Vision Technologies
CollaboratorUNKNOWN
Center for Eye Research Australia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of vision processing method in the laboratory.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.5 years.Measure the effectiveness of the vision processing method via observational qualitative and quantitative data in participant 'real world' featured environment.

Secondary

MeasureTime frameDescription
Device stability and functionality.5 years.Monitor device stability with routine ophthalmic imaging, impedance and threshold testing.
Participant experience.5 yearsDocument participant anecdotal experience with the VP method in 'real world' environments.
Participant interview.5 yearsInterview participants to capture participant experience with the ScRP, determine differences in functional outcomes and utilise this information to improve assessment of functional outcomes.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026