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

NCT07301385 | Recruiting FDA Device

• 1 other identifier: Spatial Ocular Microsurgery
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ocular microsurgery; spatial computing; eye surgery; Cataract surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  Perioperative

Secondary Outcomes (4)

• Surgeon workload during ocular surgery

  Immediately after surgery

• Surgeon-reported visualization quality and ergonomics

  Immediately after surgery

• Operating room staff workflow and usability

  Immediately after surgery

• Operative time and setup efficiency

  Perioperative

Study Arms (1)

Spatial computing visualization of cataract and anterior segment eye surgery

EXPERIMENTAL

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.

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

Interventions

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.

Spatial computing visualization of cataract and anterior segment eye surgery

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.

Spatial computing visualization of cataract and anterior segment eye surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sharp HealthCare: lead

Study Sites (1)

Sharp Otay Lakes Surgery Center

San Diego, California, 91914, United States

RECRUITING

Related Publications (5)

• Brooke, J. (1996). SUS: A quick and dirty usability scale. In P. W. Jordan, B. Thomas, B. A. Weerdmeester, & I. L. McClelland (Eds.), Usability Evaluation in Industry (pp. 189-194). London: Taylor & Francis.

  BACKGROUND

• Hart, S. G., & Staveland, L. E. (1988). Development of NASA-TLX (Task Load Index): Results of empirical and theoretical research. In P. A. Hancock & N. Meshkati (Eds.), Human Mental Workload (pp. 139-183). Amsterdam: North-Holland.

  BACKGROUND

• Mastropasqua R, Ruggeri ML, Quarta A, Tartaro R, Vecchiarino L, Corboli LV, Brescia L, Orione M, Russo A, Avitabile T, Mastropasqua L. New Mixed Reality Headset: First Exploratory Use in Intraocular Surgery and Telementoring. Ophthalmol Ther. 2025 Jul;14(7):1597-1609. doi: 10.1007/s40123-025-01117-y. Epub 2025 Apr 11.

  PMID: 40214829 BACKGROUND

• Broderick RC, Spurzem GJ, Jeffery Reeves J, Hollandsworth HM, Sandler BJ, Jacobsen GR, Longhurst CA, Horgan S. First use of augmented reality headset in minimally invasive general surgery: seeing is believing. Surg Endosc. 2025 Sep;39(9):6055-6060. doi: 10.1007/s00464-025-11985-x. Epub 2025 Jul 10.

  PMID: 40640628 BACKGROUND

• Suh Y, Shin S, Kim BY, Jeong J, Kim TI. Comparison of neck angle and musculoskeletal discomfort of surgeon in cataract surgery between three-dimensional heads-up display system and conventional microscope. Sci Rep. 2024 Sep 30;14(1):22681. doi: 10.1038/s41598-024-68630-1.

  PMID: 39349516 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Tommy Korn, MD

  Sharp Rees-Stealy Medical Group and Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommy Korn, MD

CONTACT

858-939-5400; Oppeye@sharp.com

Bishoy Said, MD

CONTACT

858-939-5400; Oppeye@sharp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist - Sharp Rees-Stealy Medical Group

Model Details: The primary purpose of this study is to evaluate the safety and workflow impact of adjunctive head-mounted spatial computing visualization during standard-of-care ocular microsurgery. All enrolled participants undergo standard-of-care ocular microsurgery with adjunctive use of a head-mounted spatial computing visualization device. There is no comparison group.

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 24, 2025
• Study Start: March 11, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: March 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)