RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form prior to participation. Who Should NOT Join This Trial: - 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 willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (1)

Sharp Otay Lakes Surgery Center

San Diego, California, United States