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
Sharp HealthCare
30 participants
Mar 11, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria6
- 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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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.
Locations(1)
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NCT07301385