Zeiss RESIGHT Disposable Lenses Evaluation Study: Investigator-initiated, Mono-center, Academic, Prospective, Interventional Case Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Ultra Wide Field lens View Angle evaluation
研究概览
简要总结
To evaluate the intra-operative efficacy of a new intra-operative viewing device.
详细描述
This study is designed to obtain more information on the efficacy of the disposable RESIGHT lenses in routine vitrectomy surgery. This information can lead to adjustments to these surgical lenses to further fine tune a device which can be used by other surgeons.
Theoretically, both the improved lens design and better resistance to fogging should improve the visualization of the retina hence facilitate the surgery, increasing the surgical safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •Patients that are scheduled for primary vitrectomy surgery to treat retinal detachment or macular disease (pucker, macular hole, vitreomacular traction).
- •Both vitrectomy-only and combined phaco-vitrectomy surgeries
- •General or local anesthesia, or combination
排除标准
- •Patient who do not have sufficient command of the Dutch language to read and understand the informed consent form
- •Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
- •Repeat vitrectomy surgery
结局指标
主要结局
Ultra Wide Field lens View Angle evaluation
时间窗: during surgery
Ultra Wide Field lens View Angle: scale from 1 (far more indentation) to 5 (far less indentation)
Ultra Wide Field lens Condensation evaluation
时间窗: during surgery
Ultra Wide Field lens Condensation: scale from 1 (far more condensation) to 5 (far less condensation)
Wide Angle lens Condensation evaluation
时间窗: during surgery
Wide Angle lens Condensation: scale from 1 (far more condensation ) to 5 (far less condensation)
Illumination appearance evaluation
时间窗: during surgery
Illumination intensity required during the surgery : scale from 1 (significantly higher) to 5 (significantly lower)
Color appearance evaluation
时间窗: during surgery
color appearance during the surgery : scale from 1 (far less natural colors) to 5 (far better natural colors )
次要结局
未报告次要终点