Pilot Study: Feasibility and Usability of a Head-Mounted Spatial Computing Device for Intraoperative Visualization During Intraocular Surgery

This is a prospective, observational, single-arm feasibility and usability study. Eligible adult patients undergoing clinically indicated intraocular surgery will have their surgeries performed according to standard of care, while the attending surgeon optionally uses Apple Vision Pro as an adjunct visualization device. No experimental procedures are performed on the patient, and standard microscopes and displays remain the primary visualization method. Approximately 40-70 surgeries will be observed across participating sites. Data will be collected intraoperatively and immediately postoperatively from the surgical record and from surgeon questionnaires.

Inclusion criteria

• Adults aged 18 years or older.
• Undergoing clinically indicated, elective ophthalmic surgery (e.g., cataract, anterior segment, retina) at a participating study site.
• Able and willing to provide informed consent prior to participation.

Exclusion criteria

• Prisoners or other vulnerable populations, unless specifically justified and approved by the IRB.
• Inability to provide consent and no legally authorized representative available.
• Cognitive impairment or language barriers precluding understanding of the consent, in the absence of a legally authorized representative.
• Procedures where any additional OR equipment is judged by the surgeon to pose unacceptable risk.
• Complex ocular pathology that could interfere with surgical visualization or increase procedural risk, including but not limited to lenticular zonule instability, previous ophthalmic surgery, corneal scarring, corneal opacity or edema, or active ocular surface infection.