Longitudinal Study of a Bionic Eye

NCT05158049 | Enrolling By Invitation DMC

• 1 other identifier: 75829
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a longitudinal observational study with participants who have been implanted with the suprachoroidal retinal prosthesis.

Conditions

Retinitis Pigmentosa; Choroideremia

Outcome Measures

Primary Outcomes (2)

• Effectiveness of vision processing method in the laboratory.

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

  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.

  5 years.

Secondary Outcomes (3)

• Device stability and functionality.

  5 years.

• Participant experience.

  5 years

• Participant interview.

  5 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants who were implanted with a suprachoroidal retinal prosthesis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Eye Research Australia: lead
• The Bionics Institute of Australia: collaborator
• Australian National University: collaborator
• Commonwealth Scientific and Industrial Research Organisation, Australia: collaborator
• Bionic Vision Technologies: collaborator

Study Sites (1)

Centre for Eye Research Australia

Melbourne E., Victoria, 3002, Australia

Location

Related Publications (1)

• 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.

  PMID: 40174607 DERIVED

Related Links

• Study of a Suprachoroidal Retinal Prosthesis
• Pilot Study of a Suprachoroidal Retinal Prosthesis

MeSH Terms

Conditions

Retinitis Pigmentosa; Choroideremia

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Choroid Diseases; Uveal Diseases; Genetic Diseases, X-Linked

Study Officials

• Penelope J Allen, FRACO, FRACS

  Center for Eye Research Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: December 9, 2021
• Primary Completion (Estimated): December 9, 2026
• Study Completion (Estimated): December 9, 2026
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)