- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07797556
Use of Apple Vision Pro as Virtual Monitor for Diagnostic and Therapeutic Procedures
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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Texas
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Houston, Texas, Estados Unidos, 77054
- Department of Surgery, Houston Methodist Hospital, Texas Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
- Clinical care team members in the operating room who are participating in any monitor-bases diagnostic/therapeutic procedures.
- 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.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Visualization quality compared to traditional monitor
Prazo: 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
|
Immediately post-procedure, assessed once per case, through study completion up to 12 months
|
|
Overall ergonomic characteristics compared to traditional monitor
Prazo: 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:
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
Prazo: 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
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
Prazo: Immediately post-procedure, assessed once per case, through study completion up to 12 months
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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:
|
Immediately post-procedure, assessed once per case, through study completion up to 12 months
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- PRO00039837
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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