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临床试验/NCT02492659
NCT02492659已完成不适用

Clinical Research of Femtosecond Laser-Assisted Cataract Surgery: Randomized Clinical Trial

Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2013年10月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

A-Yong Yu

clinical professor

Wenzhou Medical University

研究点 (1)

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