跳至主要内容
临床试验/NCT02898909
NCT02898909终止不适用

Comparison of Two Fragmentation Modalities in Femtosecond Laser-assisted Cataract Surgery

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2016年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
2
主要终点
energy delivered for lens nucleus aspiration during phacoemulsification

研究概览

简要总结

Femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed by ultrasound phacoemulsification of nuclear lens, which is then removed.

It can be assumed that fragmenting the nuclear lens in more pieces could facilitate the post-laser ultrasound phacoemulsification to extract the lens, with a lesser amount of ultrasonic energy.

The decrease of ultrasonic energy delivered during cataract surgery is beneficial to the patient because it optimizes the vitality of corneal endothelial cells, which ensure corneal transparency.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • patient aged ≥ 18 years old
  • first Femtosecond Laser-assisted Cataract Surgery scheduled
  • cataract density ≥ 3 according to the lens opacities classification system (LOCS)

排除标准

  • corneal guttata, uncontrolled glaucoma
  • shallow depth of anterior chamber
  • patient's refusal to participate in the study
  • pregnant or breast feeding patient
  • patient under legal protection
  • no health coverage

结局指标

主要结局

energy delivered for lens nucleus aspiration during phacoemulsification

时间窗: approximatively 15 minutes

ultrasound power delivered (measured in Hertz)

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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