In Vivo Evaluation of Dynamic IOP Measuring Device During Phacoemulsifcation: A Prospective Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- IOP fluctuation during each phase of surgery
研究概览
简要总结
In this modern era, surgeons prefer to perform emulsification through small micro incisions. To accomplish this safely, surgeons raise irrigation bottle heights or use forced infusion systems.We believe that this sustained rise in the IOP during micro-incision phacoemulsification for a substantial period could be detrimental to the ocular structures. Therefore, intra-operative IOP pertaining to micro-incision cataract surgery is an emerging concern.
Conventional systems for measuring IOP generate an isolated graph of continuous pressure recording. Interpretation of the IOP fluctuations from these graphs requires a two step superimposition approach to characterize the IOP changes.
详细描述
The aim of the present study was to describe a new setup for intra-operative monitoring of IOP in a clinical setting and validate it by correlating IOP differences arising with different phacoemulsification parameters in eyes undergoing microincision coaxial phacoemulsification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients undergoing phacoemulsification for uncomplicated senile cataracts
- •Cataracts from grade 1 to 3
排除标准
- •presence of glaucoma,
- •diabetic retinopathy,
- •retinal vascular disease,
- •high myopia (defined as AL > 25mm),
- •previous ocular trauma or surgery
结局指标
主要结局
IOP fluctuation during each phase of surgery
时间窗: intra-operative
次要结局
- comparison of IOP fluctuations between high and low parameters group(intra-operative)