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临床试验/NCT00781027
NCT00781027已完成4 期

Fuchs' Endothelial Dystrophy and Cataract Surgery: Can Torsional Phacoemulsification Decrease the Risk for Corneal Decompensation

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
2
主要终点
Change in central corneal thickness/corneal volume

研究概览

简要总结

The primary objective is to compare the effect of torsional phacoemulsification and longitudinal phacoemulsification on central and peripheral corneal thickness/volume after cataract surgery in patients with Fuchs' endothelial dystrophy.

详细描述

Fuchs' endothelial dystrophy is a progressive, bilateral disease of the corneal endothelium, which eventually leads to corneal decompensation. In the early stage, some patients develop visually significant cataract. During cataract surgery ultrasound (US) power is used to emulsify the lens, which leads to endothelial cell loss and tissue damage. The reduction of US power has become the primary surgical goal in cataract surgery, which is especially important in patients with Fuchs' endothelial dystrophy to limit endothelial cell loss.

In 2006, Alcon Surgical introduced a torsional mode in its phacoemulsification system (Infiniti Vision System). It includes a handpiece that produces rotary oscillations of the phacoemulsification tip and is suggested to reduce the amount of US power required to remove the cataractous nucleus, because it does not produce repulsion and breaks up the cataract by shearing and not by the conventional jackhammer effect. This reduction in US power, could lead to less endothelial cell damage than the conventional (longitudinal) mode, which is reported recently for patients with hard cataract. It is important to investigate patients with Fuchs' endothelial dystrophy, because patients with a compromised endothelial cell layer will benefit the most from less endothelial cell damage. Consequently, this lower level of endothelial damage may postpone the date of keratoplasty.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with Fuchs' endothelial dystrophy (all stages) and planning to undergo cataract surgery due to visually significant cataract
  • Patients should be 40 years of age or older

排除标准

  • Patients with Fuchs' dystrophy with a history of previous corneal or intraocular surgery
  • Patients with a planned combined surgical procedure
  • Patients who have other vision-affecting disorders than Fuchs' endothelial dystrophy

结局指标

主要结局

Change in central corneal thickness/corneal volume

时间窗: 1, 7 days and 1 , 3 and 6 months postoperatively

次要结局

  • Changes in BCVA(1, 7 days and 1, 3 and 6 months postoperatively)

研究者

申办方类型
Other

研究点 (2)

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