At a glance
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Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Feasibility and Safety Study
In Brief
A clinical study evaluating Apple Vision Pro (Head-Mounted Spatial Computing Display) and Zeiss Artevo Digital Surgical Microscope for Cataract Surgery and Cataract. Completed, enrolled 45 participants across 1 site.
Detailed 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.
Study Details
Timeline
Arms & Interventions
Participants undergo standard-of-care cataract or anterior segment ocular surgery with adjunctive use of head-mounted spatial computing visualization. There is no comparison group.
Interventions
Head-mounted spatial computing display used by the surgeon to view the real-time video output from the Zeiss Artevo digital surgical microscope. The Apple Vision Pro functions solely as an alternative visualization interface and does not acquire images, alter microscope function, modify surgical technique, or affect patient care.
FDA-cleared digital ophthalmic surgical microscope used as standard of care to visualize the operative eye during cataract and anterior segment surgery. The microscope provides the primary intraoperative imaging source for all cases, regardless of visualization display method.