NCT07301385

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Surgeons and operating room staff will be asked to complete a survey regarding workflow, setup, and communication immediately after the procedure.

Conditions

• Cataract Surgery
• Cataract

Interventions

Type	Name	Description
DEVICE	Apple Vision Pro (Head-Mounted Spatial Computing Display)	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.
DEVICE	Zeiss Artevo Digital Surgical Microscope	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.

Timeline

• Start date: 2026-03-11
• Primary completion: 2026-09-10
• Completion: 2026-09-10
• First posted: 2025-12-24
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study