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NCT Number: NCT07301385

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

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.

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Key information

Conditions

Cataract Surgery Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sharp Otay Lakes Surgery Center

San Diego, California, 91914, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apple Vision Pro (Head-Mounted Spatial Computing Display)

Device

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.

Zeiss Artevo Digital Surgical Microscope

Device

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.

Primary outcomes

  1. Intraoperative safety during head-mounted spatial computing visualization

    Time frame: Perioperative

    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.

Secondary outcomes

  1. Surgeon workload during ocular surgery

    Time frame: Immediately after surgery

    Surgeon workload measured using the National Aeronautics and Space Administration Task Load Index (NASA-TLX) questionnaire completed by the operating surgeon.

  2. Surgeon-reported visualization quality and ergonomics

    Time frame: Immediately after surgery

    Surgeon-reported assessment of visualization clarity, comfort, ergonomic strain, and overall usability using a post-procedure survey.

  3. Operating room staff workflow and usability

    Time frame: Immediately after surgery

    Operating room staff perception of workflow, communication, setup efficiency, and usability assessed using a post-procedure survey.

  4. Operative time and setup efficiency

    Time frame: Perioperative

    Total operative time and setup duration recorded from the electronic medical record and intraoperative documentation.

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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