Cataract, Cataract Surgery
Conditions
Keywords
ocular microsurgery, spatial computing, eye surgery, Cataract surgery
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.
Detailed description
Surgeons and operating room staff will be asked to complete a survey regarding workflow, setup, and communication immediately after the procedure.
Interventions
DEVICEApple 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.
DEVICEZeiss 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.
Sponsors
Sharp HealthCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative safety during head-mounted spatial computing visualization | 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
| Measure | Time frame | Description |
|---|---|---|
| Surgeon workload during ocular surgery | Immediately after surgery | Surgeon workload measured using the National Aeronautics and Space Administration Task Load Index (NASA-TLX) questionnaire completed by the operating surgeon. |
| Surgeon-reported visualization quality and ergonomics | Immediately after surgery | Surgeon-reported assessment of visualization clarity, comfort, ergonomic strain, and overall usability using a post-procedure survey. |
| Operating room staff workflow and usability | Immediately after surgery | Operating room staff perception of workflow, communication, setup efficiency, and usability assessed using a post-procedure survey. |
| Operative time and setup efficiency | Perioperative | Total operative time and setup duration recorded from the electronic medical record and intraoperative documentation. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTommy Korn, MD
Sharp Rees-Stealy Medical Group and Sharp HealthCare
Outcome results
None listed