Vitreous Surgery With Intraocular Assistance (VISIA)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- The primary outcome measure is recording of adverse events directly related to VISIA and adverse events unrelated to VISIA.
研究概览
简要总结
To Assess the Safety of Vitreous surgery with intraocular assistance (VISIA) & to identify and document with video evidence and surgeon's case report forms intraocular maneuvers that are facilitated by VISIA.
详细描述
Standard care surgery will be done with a few novel additions to facilitate the surgical procedure. Currently 3 ports are inserted by creating holes in the sclera (white part of the eye) to enter into the posterior part of the eye. When complex dissection is needed, a fourth port will be inserted. The assistant will insert light source through the 4th port. This eliminates the need for the surgeon to hold the light in one hand. Hence allows freeing of both hands for the surgeon to use a forceps in one hand to grasp and elevate membranes and a scissors in the other to cut connections between the retina and the membranes. When membranes are particularly thick, it can be difficult to dissect with a single forceps holding up the membrane. In this situation, a 5th port will be inserted allowing the assistant to insert a light source through one and a forceps though another. The surgeon will have a forceps in one hand and a scissors in another making dissection process more efficient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must meet the following criteria to be eligible for study entry:
- •Signed informed consent and authorization of use and disclosure of protected health information
- •Age ≥18 years
- •Subject will have complex retinal pathology for which it is judged that surgical objectives could be facilitated by VISIA
排除标准
- •Subjects who meet any of the following criteria will be ineligible for study entry:
- •Patients with disease processes such as macular pucker and macular hole that are generally well-managed by standard two-handed vitrectomy.
结局指标
主要结局
The primary outcome measure is recording of adverse events directly related to VISIA and adverse events unrelated to VISIA.
时间窗: 4 months
次要结局
- Surgeon's assessment of the benefits and risks of VISIA recorded on the surgical case report form.(4 months)
- Assistant's assessment of the benefits and risks of VISIA recorded on the surgical case report form.(4 months)
研究者
Peter A Campochiaro, MD
Professor of Ophthalmology and Neuroscience
Johns Hopkins University