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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorEric Rosenberg

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Apple Vision Pro Visualization System

    Device

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

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Patient undergoing cataract surgery1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eric Rosenberg

Lead sponsor

ScopeXR

Sponsor institution