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

Sharp HealthCare

Status: Not yet enrolling

Conditions: Cataract; Cataract Surgery

Treatments: Device: Zeiss Artevo Digital Surgical Microscope; Device: Apple Vision Pro (Head-Mounted Spatial Computing Display)

Study type: Interventional

Funder types: Other

Identifiers

NCT07301385

Spatial Ocular Microsurgery

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Spatial computing visualization of cataract and anterior segment eye surgery

Experimental group

Description:

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.

Treatment:

Device: Apple Vision Pro (Head-Mounted Spatial Computing Display)

Device: Zeiss Artevo Digital Surgical Microscope