Early Feasibility Study of the Polaris System for Robot-Assisted Cataract Surgery in Adults Aged 40 to 75

What this Trial Is About

Researchers are evaluating the Polaris System, a robotic device designed to assist surgeons in performing cataract surgery with improved precision and safety. This early feasibility, prospective, single-arm study focuses on patients aged 40 to 75 with uncomplicated, age-related cataracts. The goal is to assess the safety of the Polaris System by monitoring the rate of safety events over a 12-week period. Participants will undergo robot-assisted cataract surgery using the Polaris System. The procedure involves standard intraoperative eye preparation under general anesthesia, followed by docking the study eye to the device. The surgeon will use the Polaris System to perform initial surgical tasks, lens extraction, and intraocular lens implantation. After surgery, participants will have four scheduled follow-up visits over 90 days to monitor recovery and outcomes. During the study, participants will be evaluated through clinical examinations and safety assessments. Researchers will track surgical safety events up to 12 weeks after intervention to understand the devices safety profile. Participants must adhere to all study procedures, including medication regimens to prevent inflammation and infection, and attend scheduled follow-up visits. The total participation period includes the surgery and a 90-day follow-up phase.

An Early Feasibility, Prospective, Single-Arm Study of the Polaris System