CTRI/2024/04/065721招募中Unknown
A Randomized Controlled Clinical Study Evaluating Adaptive fluidics with dynamic fluid infusion boosts efficiency of phacoemulsification.
Investigator initiated study1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年4月30日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Used Fluid Volume within the eye
研究概览
简要总结
Background: Maintaining a stable intraocular pressure while doing phacoemulsification surgery by using gravity infusion may result in pressure variation, sometimes high and, that could result in damaging of intraocular tissues such as the cornea, iris and optic nerve, and induce pain or discomfort to the patient.
Purpose: The key phacoemulsification attributes of fluid volume and ultrasound parameters between variable infusion pressure system (adaptive fluidics) and gravity fed fixed infusion pressure system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Cataract grade
- •Calculated Axial length 22 to 24 mm. Pupil size on dilation more than 6.5 mm. Given consent to use device related data for scientific purpose. Clear intraocular media other than cataract. Patient willing to participate and sign informed consent.
排除标准
- •Previous intraocular or corneal surgery.
- •Traumatic cataract.
- •Irregular astigmatism.
- •Instability of keratometry or biometry measurements.
- •Patient having Microphthalmia.
- •Patient having Chronic Uveitis.
- •Patient suffering from corneal dystrophy or endothelial insufficiency.
- •Patient having active ocular diseases (active diabetic retinopathy, uncontrolled glaucoma.
结局指标
主要结局
Used Fluid Volume within the eye
时间窗: Intraoperative
次要结局
- Average Phaco Power, Absolute Phaco Time, Elapsed Phaco Time(Intraoperative)
研究者
Prof Dr Lional Raj D
Dr. Agarwals Eye Hospital
研究点 (1)
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