NCT02715388已完成不适用
Proof of Concept - Digital Electro-optical Surgical Platform as Replacement for Operational Microscopes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Depth of field of GlasScope surgical microscope
研究概览
简要总结
Evaluate the use of Elbit's digital electro-optical systems for generating detailed high quality video imaging during surgery, and thus improving the surgeon's visualization, performance and outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Patients older than
- •Pseudophakia patients with silicone oil in the vitreous cavity.
- •Silicone oil density of 1500 centistoke or 5500 CS.
- •Good corrected visual acuity (> 6/10) in the second eye.
- •Lack of additional ocular pathology that would reduce the quality of vision during surgery (corneal scar, Posterior Capsular Opacity, low transmission in the implantable lens, non-expanded pupil).
排除标准
- •Additional ocular pathology that would reduce the quality of vision during surgery (corneal scar, Posterior Capsular Opacity, low transmission in the implantable lens, non-expanded pupil).
- •The presence of heavy silicone oil (OXANE) in the vitreous cavity.
- •Posterior segment pathology in the second eye.
- •Special populations (children under the age of 18, pregnant women)
结局指标
主要结局
Depth of field of GlasScope surgical microscope
时间窗: Up to 3 days after surgery
Field of view of GlasScope surgical microscope
时间窗: Up to 3 days after surgery
3D perception of GlasScope surgical microscope
时间窗: Up to 3 days after surgery
3D perception of GlasScope surgical microscope is assessed by the surgeon ability to perform surgical gentle procedures using the surgical tools on the eye tissues - both inner and posterior parts of the eye.
次要结局
- Surgeon fatigue and neck strain (questionnaire)(Up to 7 days after surgery)
研究者
研究点 (2)
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