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

NCT07301385 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

  • Cataract Surgery
  • Cataract

Interventions

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.

Sponsors & Collaborators

  • Sharp HealthCare

    lead OTHER

Principal Investigators

  • Tommy Korn, MD · Sharp Rees-Stealy Medical Group and Sharp HealthCare

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-11
Primary Completion
2026-09-10
Completion
2026-09-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07301385 on ClinicalTrials.gov