Head-mounted 3D display for cataract and other anterior eye surgeries
Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Feasibility and Safety Study
NA · Sharp HealthCare · NCT07301385
We will test whether surgeons using the Apple Vision Pro head-mounted 3D display together with a digital surgical microscope can safely and smoothly perform cataract and other anterior eye surgeries.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sharp HealthCare (other) |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT07301385 on ClinicalTrials.gov |
What this trial studies
Surgeons will use the Apple Vision Pro head-mounted spatial computing display linked to the Zeiss Artevo 850 digital microscope during elective anterior segment procedures such as cataract surgery. The team will monitor intraoperative safety and complications while collecting immediate post-procedure surveys from surgeons and operating-room staff about workflow, setup, and communication. This is a single-center interventional workflow and safety evaluation at Sharp Otay Lakes Surgery Center. Results will focus on how the device affects surgical team experience and any patient safety signals during procedures.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for elective anterior segment eye surgery (for example cataract surgery, pterygium excision, or corneal epithelial polishing) who can provide informed consent are ideal candidates.
Not a fit: Patients with complex ocular pathology that interferes with visualization or increases procedural risk (such as lens zonular instability, prior vitreoretinal surgery in the operative eye, significant corneal scarring or edema, active ocular infection) or those unable to consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the system could improve surgeon visualization and operating-room workflow, which may reduce intraoperative errors and enhance patient safety.
How similar studies have performed: Digital surgical microscopes and some mixed-reality tools have been explored in surgery previously, but using the Apple Vision Pro as an intraoperative head-mounted visualization device in ophthalmic surgery is largely novel and not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Diego, California
- Sharp Otay Lakes Surgery Center — San Diego, California, United States (RECRUITING)
Study contacts
- Principal investigator: Tommy Korn, MD — Sharp Rees-Stealy Medical Group and Sharp HealthCare
- Study coordinator: Tommy Korn, MD
- Email: Oppeye@sharp.com
- Phone: 858-939-5400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cataract Surgery, Cataract, ocular microsurgery, spatial computing, eye surgery, Cataract surgery