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Recruiting
NCT07825337
Pilot Study: Feasibility and Usability of a Head-Mounted Spatial Computing Device for Intraoperative Visualization During Intraocular Surgery
Conditions: Cataract Surgery
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: No
Enrollment: 70
Sponsor: Eric Rosenberg
Location: Long Island Ambulator Surgery Center Brentwood New York
Summary
To evaluate the feasibility and usability of Apple Vision Pro as an adjunct visualization and information display tool during ophthalmic surgery.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07825337). StuddyBuddy aggregates publicly available trial information.