Enrolling by invitation

NCT Number: NCT07797556

Use of Apple Vision Pro as Virtual Monitor for Diagnostic and Therapeutic Procedures

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.

Enrolling by invitation

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Key information

Conditions

Device Convenience Device Performance Ergonomics Surgeons' Rating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery, Houston Methodist Hospital, Texas Medical Center

Houston, Texas, 77054, United States

About this study

Study Procedures

Enrolled physicians use the Apple Vision Pro (AVP) in place of a traditional monitor for the duration of each participating case. The AVP is worn from intra-operative visualization setup (typically at incision or first use of the imaging system) until the conclusion of the primary intra-operative visualization phase.

No modifications are made to the physician's standard operative technique, instrumentation, or intra-operative workflow apart from substitution of the display device. If the physician determines at any point during a case that the AVP cannot support safe completion of the procedure, they may revert to the traditional monitor without penalty; such cases are documented with a structured reason for conversion.

Data Collection Instruments

Data are collected via a structured post-case survey administered in REDCap immediately following case completion. The survey captures:

Case characteristics: date, operating physician, specialty, procedure name, operative time, and patient information (height, weight, body mass index).

Overall visualization rating: a single-item 5-point Likert-type comparative scale (1 = much worse than a traditional monitor; 5 = much better).

NASA Task Load Index (NASA-TLX): the raw unweighted version, comprising six subscales (mental demand, physical demand, temporal demand, performance, effort, frustration). The overall NASA-TLX score is computed as the mean of the six subscale ratings.

Per-case ergonomic symptom checklist: twelve pre-specified symptom dimensions (eye strain, headache, dizziness, nausea, blurred or double vision, light sensitivity, puffiness of the eyelids, face discomfort, neck discomfort, shoulder discomfort, back discomfort, and other AVP-related discomfort). Each symptom is captured using a two-step response format: first, a yes/no screen for whether the symptom was experienced; then, if experienced, a comparative severity rating (1 = much worse than a traditional monitor to 5 = much better). Cases in which a symptom is not experienced are coded as 0.

Feasibility of using AVP: binary yes/no field with a structured failure reason if the case could not be completed on the AVP (device failure, inadequate visual quality, negative ergonomic factors, or other).

Data Management

All study data are stored in REDCap hosted on Houston Methodist's institutional server infrastructure, which is HIPAA-compliant and access-controlled. Patient identifiers (medical record numbers) are used at the point of data entry to link procedure-specific metadata (e.g., patient BMI, operative timing from the electronic health record). Prior to analysis, all patient identifiers are removed and cases are analyzed using de-identified case-level records only.

Access to the REDCap project is restricted to study personnel with active IRB approval and REDCap credentials, managed through the Houston Methodist REDCap administrative team. Role-based user rights limit editing and export privileges according to each user's study responsibilities.

Quality Assurance

Structured, coded response fields (radio buttons, validated numeric inputs, checkbox groupings) are used throughout the data collection instrument to minimize free-text entry and reduce data entry error. Branching logic is used to ensure that follow-up items are displayed only when relevant, reducing survey burden and preventing invalid response combinations.

Range and consistency checks are built into the REDCap instrument, including validated time and integer entry, and permitted value ranges for continuous variables. Periodic data quality review is conducted by the study coordinator, including checks for completeness, out-of-range values, internal consistency between related fields, and follow-up on missing or incomplete records. Data queries are resolved with the responsible surgeon or clinical staff.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Overall Visualization quality compared to traditional monitor

Time frame: Immediately post-procedure, assessed once per case, through study completion up to 12 months
Participants would rate their experience of using AVP as virtual monitor compared to traditional monitor, rated on a 5-point Likert scale
- = Much worse than a monitor
- = Slightly worse than a monitor
- = The same as a monitor
- = Slightly better than a monitor
- = Much better than a monitor
Overall ergonomic characteristics compared to traditional monitor

Time frame: Immediately post-procedure, assessed once per case, through study completion up to 12 months
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:
- = Much worse than a monitor
- = Slightly worse than a monitor
- = The same as a monitor
- = Slightly better than a monitor
- = 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
NASA-TLX survey

Time frame: Immediately post-procedure, assessed once per case, through study completion up to 12 months
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.
Feasibility of using AVP

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

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

Use of Apple Vision Pro as a Head-mounted Virtual Monitor for Diagnostic and Therapeutic Procedures

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Sep 1, 2026
Registry last updated: Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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