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

2026年8月27日 更新者:The Methodist Hospital Research Institute

Use of Apple Vision Pro as a Head-mounted 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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

4

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Texas
      • Houston、Texas、美国、77054
        • Department of Surgery, Houston Methodist Hospital, Texas Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

  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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Overall Visualization quality compared to traditional monitor
大体时间: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

  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
大体时间: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:

  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
大体时间: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.

Immediately post-procedure, assessed once per case, through study completion up to 12 months
Feasibility of using AVP
大体时间: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
Immediately post-procedure, assessed once per case, through study completion up to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年6月16日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年5月1日

研究注册日期

首次提交

2026年8月24日

首先提交符合 QC 标准的

2026年8月27日

首次发布 (实际的)

2026年9月1日

研究记录更新

最后更新发布 (实际的)

2026年9月1日

上次提交的符合 QC 标准的更新

2026年8月27日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

We will not share IPD at the moment.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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