Evaluation of an Iris Dilatation Ring in Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Proportion of patients with dilated iris ≥ 6 mm
研究概览
简要总结
During cataract surgery, it is necessary to dilate the iris in order to remove the crystalline lens and position the implant. The diameter of the optical implant being 6 mm, in case of capsulorhexis crystalline access 5.5 mm, the expansion should be at least 6 mm.
At pre-operative consultation, the iris is always dilated by instillation of eye drops and measured at the slitlamp. For patients with an inadequate dilation, the intervention requires the use of a mechanical dilatation device.
This study aims to assess the value of an alternative dilatation ring to Malyugin ring, which can be inserted and removed through an incision of less than 2 mm in diameter, due to its size smaller than that of the Malyugin ring.
Our hypothesis is that this Bhattacharjee ring ensures sufficient and stable iris dilation during surgery, enabling implant placement in good conditions.
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
- 否
入选标准
- •Patient with programmed cataract surgery under topical or local anesthesia
- •Need to use a dilatation ring during operation, highlighted by iris dilatation ≤ 6 mm on slitlamp, after mydriatic solution and 10% phenylephrine eye drops instillation
排除标准
- •Pregnant or breastfeeding woman
- •Patient's refusal to participate in the study
- •Patient non covered by health insurance
- •Complete iridectomy
- •Tearing of iris sphincter
- •Important posterior synechiae (when the iris is attached to the anterior surface of the implant)
- •Anterior chamber very deep (depth of the anterior chamber lower than 1mm after injection of the viscous product)
研究组 & 干预措施
Bhattacharjee ring
干预措施: Bhattacharjee ring (Device)
结局指标
主要结局
Proportion of patients with dilated iris ≥ 6 mm
时间窗: Immediately after ring insertion
次要结局
- Proportion of patients with ≥ 6mm iris dilation after surgery(Just before ring removal)
- Change for Malyugin ring during surgery(Just before ring insertion)
- Proportion of patients with iris retraction ≤ 4 mm immediately(Immediatly after ring removal)
- Proportion of patients with dilated iris ≥ 6 mm after instillation of dilating eye drops(Immediately before ring insertion)
- Surgeon feeling operational conditions on an visual analogic scale(Immediatly after ring insertion)