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

September 12, 2026 updated by: Eric Rosenberg
To evaluate the feasibility and usability of Apple Vision Pro as an adjunct visualization and information display tool during ophthalmic surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Brentwood, New York, United States, 11717
        • Recruiting
        • Long Island Ambulator Surgery Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient undergoing cataract surgery
Cataract surgery patients
Device: Apple Vision Pro Visualization System
Apple Vision Pro as an adjunct intraoperative visualization and information display tool during ophthalmic surgery.[

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuity of care
Time Frame: 1 year
Completion of surgery without device-related interruption that requires abandoning the surgery or conversion to an alternative procedure.
1 year
Questionnaire
Time Frame: 1 year
XR Usability Questionnaire (XR-UQ) scores for each case.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eric Rosenberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2028

Study Registration Dates

First Submitted

August 30, 2026

First Submitted That Met QC Criteria

September 12, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 12, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1408687

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Novel technology with limited surgeons using 3D digital microscopes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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