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

27 août 2026 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Texas
      • Houston, Texas, États-Unis, 77054
        • Department of Surgery, Houston Methodist Hospital, Texas Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

  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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Overall Visualization quality compared to traditional monitor
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 juin 2025

Achèvement primaire (Estimé)

1 mai 2027

Achèvement de l'étude (Estimé)

1 mai 2027

Dates d'inscription aux études

Première soumission

24 août 2026

Première soumission répondant aux critères de contrôle qualité

27 août 2026

Première publication (Réel)

1 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • PRO00039837

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

We will not share IPD at the moment.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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