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Recruiting NCT07301385

Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study

Trial Parameters

Condition Cataract Surgery
Sponsor Sharp HealthCare
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-03-11
Completion 2026-09-10
Interventions
Apple Vision Pro (Head-Mounted Spatial Computing Display)Zeiss Artevo Digital Surgical Microscope

Brief Summary

The purpose of this research is to evaluate the use of the research study device, the Apple Vision Pro head-mounted spatial computing display, with the Zeiss Artevo 850 digital microscope system, for the visualization during cataract and anterior segment surgery. Specifically, researchers will assess how the study device affects surgical staff experience and workflow and monitor for patient safety and intraoperative complications associated with the use of the device.

Eligibility Criteria

Inclusion Criteria: * Adults aged 18 years or older * Scheduled to undergo elective anterior segment eye surgery, including: cataract surgery, pterygium excision, corneal epithelial polishing * Able and willing to provide informed consent prior to participation. Exclusion Criteria: * Complex ocular pathology that could interfere with surgical visualization or increase procedural risk, including but not limited to: * Lens zonular instability or phacodonesis * Prior vitreoretinal surgery (e.g., vitrectomy, scleral buckle, glaucoma drainage device) in the operative eye * Significant corneal scarring, opacity, or edema * Active ocular surface inflammation or infection * Cognitive impairment or language barriers that prevent the patient from understanding and signing informed consent.

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