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Enrolling by invitation NCT05158049

Longitudinal Study of a Bionic Eye

Observational Retinitis Pigmentosa Choroideremia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Retinitis Pigmentosa, Choroideremia. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Longitudinal Observation and Assessment of the Suprachoroidal Retinal Prostheses

Overview

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.

Primary outcome measures

  • Effectiveness of vision processing method in the laboratory. [Time frame: 5 years.]
  • Effectiveness of vision processing method in the 'real world' featured environment. [Time frame: 5 years.]
Secondary outcome measures (3)
  • Device stability and functionality. [Time frame: 5 years.]
  • Participant experience. [Time frame: 5 years]
  • Participant interview. [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Australia · 1 center
  • Centre for Eye Research Australia — Melbourne E.

Publications

  • 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

Identifiers

NCT: NCT05158049 · 75829

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗