Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Feasibility and Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Intraoperative safety during head-mounted spatial computing visualization
研究概览
简要总结
The purpose of this research is to evaluate the use of the research study device, the Apple Vision Pro head-mounted spatial computing display, with the Zeiss Artevo 850 digital microscope system, for the visualization during cataract and anterior segment surgery. Specifically, researchers will assess how the study device affects surgical staff experience and workflow and monitor for patient safety and intraoperative complications associated with the use of the device.
详细描述
Surgeons and operating room staff will be asked to complete a survey regarding workflow, setup, and communication immediately after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Scheduled to undergo elective anterior segment eye surgery, including: cataract surgery, pterygium excision, corneal epithelial polishing
- •Able and willing to provide informed consent prior to participation.
排除标准
- •Complex ocular pathology that could interfere with surgical visualization or increase procedural risk, including but not limited to:
- •Lens zonular instability or phacodonesis
- •Prior vitreoretinal surgery (e.g., vitrectomy, scleral buckle, glaucoma drainage device) in the operative eye
- •Significant corneal scarring, opacity, or edema
- •Active ocular surface inflammation or infection
- •Cognitive impairment or language barriers that prevent the patient from understanding and signing informed consent.
研究组 & 干预措施
Spatial computing visualization of cataract and anterior segment eye surgery
Participants undergo standard-of-care cataract or anterior segment ocular surgery with adjunctive use of head-mounted spatial computing visualization. There is no comparison group.
干预措施: Zeiss Artevo Digital Surgical Microscope (Device)
Spatial computing visualization of cataract and anterior segment eye surgery
Participants undergo standard-of-care cataract or anterior segment ocular surgery with adjunctive use of head-mounted spatial computing visualization. There is no comparison group.
干预措施: Apple Vision Pro (Head-Mounted Spatial Computing Display) (Device)
结局指标
主要结局
Intraoperative safety during head-mounted spatial computing visualization
时间窗: Perioperative
Safety will be assessed by the proportion of surgical cases completed using head-mounted spatial computing visualization without conversion to standard microscope visualization due to device-related issues, and by the occurrence of intraoperative complications potentially related to visualization, including posterior capsule rupture, vitreous loss, corneal or scleral injury, or other unplanned intraoperative events.
次要结局
- Surgeon workload during ocular surgery(Immediately after surgery)
- Surgeon-reported visualization quality and ergonomics(Immediately after surgery)
- Operating room staff workflow and usability(Immediately after surgery)
- Operative time and setup efficiency(Perioperative)
研究者
Tommy Korn, MD
Ophthalmologist - Sharp Rees-Stealy Medical Group
Sharp HealthCare