Efficacy of the Canabrava/s Pupil Expansion Device in Cataract Surgery With Small Pupils: The First 30 Cases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 主要终点
- Incidence of adverse events
研究概览
简要总结
To evaluate the intraoperative stability, safety and overall efficacy of the Canabrava Ring (AJL - SPAIN) when used to expand pupils with less diameter than 5 mm and pupils with sphincter synechiae.
详细描述
In this consecutive case series, 30 eyes of 29 patients underwent cataract surgery using a new disposable small-pupil expansion device, Canabrava's Ring (AJL Ophthalmic, Spain). It is the first iris expansion ring produced with indents that do not align with each other in the superior and inferior regions, resulting in a small vertical length (0.4mm) that minimizes risk of endothelial contact. All eyes had poorly preoperatively dilated pupils of less than 5mm. Fifteen eyes had significant infective or traumatic pathology preoperatively. Vertical and horizontal pupil diameters were evaluated pre-, intra- and 1 month postoperatively, and were used to calculate pupil circumference. Intraoperative and postoperative pupil circumference comprised the primary outcomes of interest.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinical indication for cataract surgery, age of at least 18 years, pupil diameter less than 5mm after dilation with phenylephrine and tropicamide, and lens with any degree of opacity.
排除标准
- •eyes unable to perceive light during visual acuity testing, pupils with a diameter greater than 5mm and clear lenses
研究组 & 干预措施
Cana's Ring group
The device Cana's Ring was used during cataract surgery on these patients.
干预措施: Cana's Ring (Device)
结局指标
主要结局
Incidence of adverse events
时间窗: 30 days after surgery
Safety of the material of the device from break, lesion of eye structures and iritis
次要结局
- Stability of the device during surgery(During surgery)