Longitudinal Study of a Bionic Eye

Retinitis Pigmentosa Clinical Trial

Official title:

Longitudinal Observation and Assessment of the Suprachoroidal Retinal Prostheses

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05158049
• Other study ID #: 75829
• Status: Enrolling by invitation
• Start date: December 9, 2021
• Est. completion date: December 9, 2026

Study information

• Verified date: March 2023
• Source: Center for Eye Research Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 7
• Est. completion date: December 9, 2026
• Est. primary completion date: December 9, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Choroideremia
• Retinitis
• Retinitis Pigmentosa

Locations

Country	Name	City	State
Australia	Centre for Eye Research Australia	Melbourne E.	Victoria

Sponsors (5)

Lead Sponsor	Collaborator
Center for Eye Research Australia	Australian National University, Bionic Vision Technologies, Bionics Institute, Commonwealth Scientific and Industrial Research Organisation, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of vision processing method in the laboratory.	Measure effectiveness of of the vision processing method via observational and quantitative data.	5 years.
Primary	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	Device stability and functionality.	Monitor device stability with routine ophthalmic imaging, impedance and threshold testing.	5 years.
Secondary	Participant experience.	Document participant anecdotal experience with the VP method in 'real world' environments.	5 years
Secondary	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.	5 years

External Links

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