NCT07797556

Brief Summary

This study evaluates whether the Apple Vision Pro (AVP), a head-mounted display device, can be used as a virtual monitor for performing diagnostic and therapeutic procedures. Participating surgeons wear the Apple Vision Pro instead of viewing a traditional operating room monitor while performing their normal cases. The main goals of the study are to assess: (1) visualization quality (how is the visualization quality when compared to using a traditional monitor), (2) ergonomic characteristics (ergonomics such as neck pain, back pain, shoulder discomfort and when compared to using a traditional monitor), (3) task-load index (NASA-TLX workload while using the device), and (4) feasibility (whether cases can be completed successfully using the device). The study team hypothesizes that using the Apple Vision Pro will provide superior visual resolution and improved ergonomics compared with viewing on a standard 32-inch 4K boom-mounted operating room monitor. After each case, surgeons rate their experience across these outcomes based on their previous experience of using a traditional monitor.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jun 2025May 2027

Study Start

First participant enrolled

June 16, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

1.9 years

First QC Date

August 24, 2026

Last Update Submit

August 27, 2026

Conditions

Keywords

apple vision provirtual monitordiagnostic procedurestherapeutic procedures

Outcome Measures

Primary Outcomes (4)

  • Overall Visualization quality compared to traditional monitor

    Participants would rate their experience of using AVP as virtual monitor compared to traditional monitor, rated on a 5-point Likert scale 1. = Much worse than a monitor 2. = Slightly worse than a monitor 3. = The same as a monitor 4. = Slightly better than a monitor 5. = Much better than a monitor

    Immediately post-procedure, assessed once per case, through study completion up to 12 months

  • Overall ergonomic characteristics compared to traditional monitor

    After each case, the participating physician completes a two-part symptom assessment: Part 1 - Symptom Screening: Participant is presented with a checklist of 12 symptoms potentially associated with wearing a head-mounted display. Participant selects all symptoms experienced during the case. If no symptoms were experienced, participant selects "I did not experience any of these symptoms." Part 2 - Comparative Severity Rating: For each symptom marked as experienced in Part 1, participant rates how it compared to symptoms typically experienced when using a traditional surgical monitor: 1. = Much worse than a monitor 2. = Slightly worse than a monitor 3. = The same as a monitor 4. = Slightly better than a monitor 5. = Much better than a monitor Symptoms assessed: Eye strain (tired eyes, burning, stinging, or itchiness) Headache Dizziness Nausea Blurred or double vision Light sensitivity Puffiness of the eyelids Face pain Neck pain or discomfort Shoulder pain Back pain Other discomfort

    Immediately post-procedure, assessed once per case, through study completion up to 12 months

  • NASA-TLX survey

    Participants will complete a NASA-Task load index survey which assesses the workload during each procedure, rated across 6 dimensions on a scale of 0-100 * Mental demand * Physical demand * Temporal demand * Performance * Effort * Frustration The six ratings are averaged into a single overall workload score with higher scores indicating greater perceived workload.

    Immediately post-procedure, assessed once per case, through study completion up to 12 months

  • Feasibility of using AVP

    Data will be collected on conversion events (transition from AVP as the primary monitor to a standard monitor). Each conversion will be categorized into one of the three pre-specified reasons: * Device failure (e.g., technical malfunction, connectivity loss, battery or power issue) * Negative ergonomics factors (e.g., discomfort, fit issue, visual or physical fatigue precluding continued use) * Inadequate imaging for procedural completion (e.g., insufficient resolution, depth perception, or field of view for task at hand) * Any other events that lead to conversion

    Immediately post-procedure, assessed once per case, through study completion up to 12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Clinical care team members in the operating room who are participating in any monitor-bases diagnostic/therapeutic procedures. 2. Patients who are adults who are 18 years of age or older and: Who are capable of giving informed consent. Who are undergoing any monitor-based diagnostic/therapeutic procedure performed at Houston Methodist Hospital.

You may qualify if:

  • Vision correction with contacts and Lasik are acceptable.
  • Surgeons who wear glasses and who have corrective lens inserts in the Apple Vision Pro.

You may not qualify if:

  • Vision correction with glasses and no custom lens inserts for the Apple Vision Pro.
  • Significant vision impairment that is not corrected.
  • Pregnant women: A known risk when wearing the AVP is nausea and dizziness; we do not want to exacerbate this.
  • Adults with known seizure disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Houston Methodist Hospital, Texas Medical Center

Houston, Texas, 77054, United States

Location

Related Publications (1)

  • Wang T, Zheng B. 3D presentation in surgery: a review of technology and adverse effects. J Robot Surg. 2019 Jun;13(3):363-370. doi: 10.1007/s11701-018-00900-3. Epub 2018 Dec 15.

Related Links

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

September 1, 2026

Study Start

June 16, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

September 1, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

We will not share IPD at the moment.

Locations