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.
Surgeons and operating room staff will be asked to complete a survey regarding workflow, setup, and communication immediately after the procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
45
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.
Sharp Otay Lakes Surgery Center
San Diego, California, United States
Intraoperative safety during head-mounted spatial computing visualization
Safety will be assessed by the proportion of surgical cases completed using head-mounted spatial computing visualization without conversion to standard microscope visualization due to device-related issues, and by the occurrence of intraoperative complications potentially related to visualization, including posterior capsule rupture, vitreous loss, corneal or scleral injury, or other unplanned intraoperative events.
Time frame: Perioperative
Surgeon workload during ocular surgery
Surgeon workload measured using the National Aeronautics and Space Administration Task Load Index (NASA-TLX) questionnaire completed by the operating surgeon.
Time frame: Immediately after surgery
Surgeon-reported visualization quality and ergonomics
Surgeon-reported assessment of visualization clarity, comfort, ergonomic strain, and overall usability using a post-procedure survey.
Time frame: Immediately after surgery
Operating room staff workflow and usability
Operating room staff perception of workflow, communication, setup efficiency, and usability assessed using a post-procedure survey.
Time frame: Immediately after surgery
Operative time and setup efficiency
Total operative time and setup duration recorded from the electronic medical record and intraoperative documentation.
Time frame: Perioperative
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