Longitudinal Study of a Bionic Eye

• Conditions: Retinitis Pigmentosa; Choroideremia

• Registration Number: NCT05158049
• Lead Sponsor: Center for Eye Research Australia

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.

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Study Start: 2021-12-09
• Study First Posted: 2021-12-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2026-12-09
• Study Completion: 2026-12-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
Effectiveness of vision processing method in the laboratory.	5 years.	Measure effectiveness of of the vision processing method via observational and quantitative data.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre for Eye Research Australia; 🇦🇺 Melbourne E., Victoria, Australia