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RecruitingNCT07825337Updated Sep 17, 2026

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

An observational study in Cataract Surgery, sponsored by Eric Rosenberg. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Eric Rosenberg · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
70
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cataract Surgery

Keywords

  • Spatial computing
  • Augmented Reality
  • Cataract Surgery
  • Apple Vision Pro
  • Heads-up Display
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
70 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • Patient undergoing cataract surgery

    Cataract surgery patients

    Device: Apple Vision Pro Visualization System

Interventions

  • DeviceApple Vision Pro Visualization System

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

05

What researchers measure

Primary outcomes

  1. Continuity of care

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

    Time frame: 1 year

  2. Questionnaire

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

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Long Island Ambulator Surgery Center
    Brentwood, New York 11717, United States
    Recruiting
07

References and documents

Publications

  • 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. PubMed 39140319 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 15, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Novel technology with limited surgeons using 3D digital microscopes.

08

Registry details

Key details

Study ID
NCT07825337
Lead sponsor
Eric Rosenberg
Responsible party
Eric Rosenberg (Chief Medical Officer, ScopeXR) — Sponsor-investigator
First posted
Sep 17, 2026
Start date
Aug 30, 2026
Primary completion
Aug 30, 2027 (estimated)
Completion
Aug 30, 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Kathy Lemier
Contact
eric@scopeXR.com
6319573355

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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