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

NCT ID: NCT07301385

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-06-01

Brief Summary

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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.

Detailed Description

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

Conditions

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Cataract Surgery Cataract

Keywords

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ocular microsurgery spatial computing eye surgery Cataract surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Spatial computing visualization of cataract and anterior segment eye surgery

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.

Group Type EXPERIMENTAL

Apple Vision Pro (Head-Mounted Spatial Computing Display)

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sharp HealthCare

OTHER

Sponsor Role lead

Responsible Party

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Tommy Korn, MD

Ophthalmologist - Sharp Rees-Stealy Medical Group

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tommy Korn, MD

Role: PRINCIPAL_INVESTIGATOR

Sharp Rees-Stealy Medical Group and Sharp HealthCare

Locations

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Sharp HealthCare

San Diego, California, United States

Site Status

Countries

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United States

Central Contacts

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Tommy Korn, MD

Role: CONTACT

Phone: 858-939-5400

Email: [email protected]

Bishoy Said, MD

Role: CONTACT

Phone: 858-939-5400

Email: [email protected]

References

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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.

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 40214829 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40640628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39349516 (View on PubMed)

Other Identifiers

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Spatial Ocular Microsurgery

Identifier Type: -

Identifier Source: org_study_id