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

NCT07825337 | Recruiting

• 1 other identifier: 1408687
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the feasibility and usability of Apple Vision Pro as an adjunct visualization and information display tool during ophthalmic surgery.

Conditions

Cataract Surgery

Keywords

Spatial computing; Augmented Reality; Cataract Surgery; Apple Vision Pro; Heads-up Display

Outcome Measures

Primary Outcomes (2)

• Continuity of care

  Completion of surgery without device-related interruption that requires abandoning the surgery or conversion to an alternative procedure.

  1 year

• Questionnaire

  XR Usability Questionnaire (XR-UQ) scores for each case.

  1 year

Study Arms (1)

Patient undergoing cataract surgery

Cataract surgery patients

Device: Apple Vision Pro Visualization System

Interventions

Apple Vision Pro Visualization System DEVICE

Apple Vision Pro as an adjunct intraoperative visualization and information display tool during ophthalmic surgery.\[

Patient undergoing cataract surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any patient having surgery performed who meets the inclusionary/exclusionary criteria at the Long Island Ambulatory Surgery Center, Brentwood, NY 11717

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eric Rosenberg: lead

Study Sites (1)

Long Island Ambulator Surgery Center

Brentwood, New York, 11717, United States

RECRUITING

Related Publications (1)

• Orione M, Rubegni G, Tartaro R, Alberghina A, Fallico M, Orione C, Russo A, Tosi GM, Avitabile T. Utilization of apple vision pro in ophthalmic surgery: A pilot study. Eur J Ophthalmol. 2025 Mar;35(2):715-721. doi: 10.1177/11206721241273574. Epub 2024 Aug 14.

  PMID: 39140319 RESULT

Central Study Contacts

Kathy Lemier

CONTACT

6319573355; eric@scopeXR.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 17, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)