Cataract Surgery
Conditions
Keywords
Spatial computing, Augmented Reality, Cataract Surgery, Apple Vision Pro, Heads-up Display
Brief summary
To evaluate the feasibility and usability of Apple Vision Pro as an adjunct visualization and information display tool during ophthalmic surgery.
Detailed description
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.
Interventions
DEVICEApple Vision Pro Visualization System
Apple Vision Pro as an adjunct intraoperative visualization and information display tool during ophthalmic surgery.\[
Sponsors
Eric Rosenberg
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuity of care | 1 year | Completion of surgery without device-related interruption that requires abandoning the surgery or conversion to an alternative procedure. |
| Questionnaire | 1 year | XR Usability Questionnaire (XR-UQ) scores for each case. |
Countries
United States
Contacts
CONTACTKathy Lemier
Outcome results
None listed