Clinical Research of Femtosecond Laser-Assisted Cataract Surgery: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- the proteins in the aqueous humor after femtosecond laser operation
研究概览
简要总结
Since femtosecond laser was approved for cataract surgery by FDA in 2010, femtosecond laser assisted cataract surgery (FLACS) has demonstrated high precision of capsulotomy, reduced phacoemulsification power and time, and comparable refractive outcome in clinic.
It is still unknown whether there are toxic substances produced due to photochemical or high-energy physical effect of femtosecond laser during FLACS.
详细描述
Phacoemulsification is one of the main surgical procedures for cataract surgery owing to the advantages of small incisions and rapid recovery. However, the surgical outcome of phacoemulsification can be negatively affected due to the problem of accuracy and repeatability for capsulorhexis, and the corneal endothelial cell damage by ultrasound energy.To overcome those problems from the phacoemulsification, femtosecond laser-assisted cataract surgery (FLACS) had been used in the past few years and showed unique advantages.
The purpose of this study is to investigate the preliminary clinical outcomes of femtosecond laser-assisted cataract surgery.This prospective comparative study enrolled consecutive patients,will be randomly assigned to trial group underwent FLACS and control group underwent conventional cataract surgery.
The phacoemulsification time, energy, and complications during operation were recorded.
The anterior capsule and aqueous humor were collected. Morphology of the cutting edge and cells of anterior capsule was assessed by light microscopy. The proteins in the aqueous humor were identified by mass spectrometry . Electrolyte in the aqueous humor was detected by a chemistry analyzer. Postoperative refraction at 1 day, 1 week, 1 and 3 months, the capsulorhexis size and corneal endothelial density at 1 and 3 months were also measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 38 Years 至 86 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •normal cornea
- •dilated pupillary diameter greater than 6mm
- •no local or systemic contraindications to cataract surgery
排除标准
- •corneal pathological changes
- •ocular inflammation
- •previous ocular trauma or surgery
结局指标
主要结局
the proteins in the aqueous humor after femtosecond laser operation
时间窗: day 1
次要结局
- the electrolyte in the aqueous humor after femtosecond laser operation(day 1)
- morphology of the anterior capsule after femtosecond laser operation(day 1)
研究者
A-Yong Yu
clinical professor
Wenzhou Medical University
