ClinicalTrials.gg
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

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
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

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Keywords

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

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 70 is below the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

This is the only study on the registry with Eric Rosenberg as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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.\[

06

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

07

Study locations

1 of 1 sites recruiting
  • Long Island Ambulator Surgery Center
    Brentwood, New York 11717, United States
    Recruiting
08

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

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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