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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.
Surgeons and operating room staff will be asked to complete a survey regarding workflow, setup, and communication immediately after the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after surgery |
| Surgeon-reported visualization quality and ergonomics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tommy Korn, MD | Sharp Rees-Stealy Medical Group and Sharp HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Otay Lakes Surgery Center | San Diego | California | 91914 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 40214829 | 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. | |
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IPD will not be shared to protect patient confidentiality. Only aggregated, de-identified data will be published in scientific reports on visualization performance, workflow, and surgeon and operating room staff feedback.
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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.
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|
| 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. |
|
Surgeon-reported assessment of visualization clarity, comfort, ergonomic strain, and overall usability using a post-procedure survey. |
| 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. | Immediately after surgery |
| Operative time and setup efficiency | Total operative time and setup duration recorded from the electronic medical record and intraoperative documentation. | Perioperative |
| 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. |
| 39349516 | 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. |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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