A Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis: A Single-Arm Clinical Trial of Feasibility.

ABSTRACT:

Purpose

To assess the feasibility of a second-generation (44-channel) suprachoroidal retinal prosthesis for provision of functional vision in recipients with end-stage retinitis pigmentosa (RP) over 2.7 years.

Design

Prospective, single-arm, unmasked interventional clinical trial.

Participants

Four participants, with advanced RP and bare-light perception vision.

Methods

The 44-channel suprachoroidal retinal prosthesis was implanted in the worse-seeing eye. Device stability, functionality, and adverse events were investigated at approximately 12-week intervals up to 140 weeks (2.7 years) postdevice activation.

Main outcome measures

Serious adverse event (SAE) reporting, visual response outcomes, functional vision outcomes, and quality-of-life outcomes.

SUBMITTER: Petoe MA 

PROVIDER: S-EPMC11426041 | biostudies-literature | 2025 Jan-Feb

REPOSITORIES: biostudies-literature