Pilot Study: Feasibility and Usability of a Head-Mounted Spatial Computing Device for Intraoperative Visualization During Intraocular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Continuity of care
研究概览
简要总结
To evaluate the feasibility and usability of Apple Vision Pro as an adjunct visualization and information display tool during ophthalmic surgery.
详细描述
This is a prospective, observational, single-arm feasibility and usability study. Eligible adult patients undergoing clinically indicated intraocular surgery will have their surgeries performed according to standard of care, while the attending surgeon optionally uses Apple Vision Pro as an adjunct visualization device. No experimental procedures are performed on the patient, and standard microscopes and displays remain the primary visualization method. Approximately 40-70 surgeries will be observed across participating sites. Data will be collected intraoperatively and immediately postoperatively from the surgical record and from surgeon questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Undergoing clinically indicated, elective ophthalmic surgery (e.g., cataract, anterior segment, retina) at a participating study site.
- •Able and willing to provide informed consent prior to participation.
排除标准
- •Prisoners or other vulnerable populations, unless specifically justified and approved by the IRB.
- •Inability to provide consent and no legally authorized representative available.
- •Cognitive impairment or language barriers precluding understanding of the consent, in the absence of a legally authorized representative.
- •Procedures where any additional OR equipment is judged by the surgeon to pose unacceptable risk.
- •Complex ocular pathology that could interfere with surgical visualization or increase procedural risk, including but not limited to lenticular zonule instability, previous ophthalmic surgery, corneal scarring, corneal opacity or edema, or active ocular surface infection.
研究组 & 干预措施
Patient undergoing cataract surgery
Cataract surgery patients
干预措施: Apple Vision Pro Visualization System (Device)
结局指标
主要结局
Continuity of care
时间窗: 1 year
Completion of surgery without device-related interruption that requires abandoning the surgery or conversion to an alternative procedure.
Questionnaire
时间窗: 1 year
XR Usability Questionnaire (XR-UQ) scores for each case.
次要结局
未报告次要终点
研究者
Eric Rosenberg
Chief Medical Officer
ScopeXR