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临床试验/NCT02096627
NCT02096627已完成不适用

Comparison of Femtosecond Laser Assisted Cataract Surgery to Conventional Phacoemulsification Cataract Surgery on Corneal Endothelial Cell Loss

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2014年5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
154
试验地点
1
主要终点
endothelial cell density three months after conventional CEIOL or FLACS compared to baseline

研究概览

简要总结

In this project, the investigators aim to compare the safety, efficacy, and predictability outcomes of conventional CEIOL surgery to Femtosecond-laser-assisted CEIOL (FLACS) in an effort to improve cataract surgery outcomes. The investigators hypothesis is that FLACS may lead to preservation of endothelial cells compared to conventional CE IOL.

详细描述

This study will only include patients who are eligible to undergo cataract surgery. All patients will receive treatment that is FDA approved for cataract surgery. Because all study participants will have been scheduled for elective cataract extraction regardless of their participation in this study, there will be little or no additional surgical risk associated with participation. A total of 720 patients are expected to be enrolled in the study during a period of 2 years. The investigators will recruit patients with bilateral operable cataracts. One eye will undergo cataract surgery using conventional cataract extraction technique including phacoemulsification whereas the second eye will undergo FLACS. No significant increased risk to the patient is expected in either arm of the study compared to routine cataract surgery. The patients will be examined as per previous post-operative cataract surgery guidelines on POD1, POW1, POM1, POM3, POM6, POY1 and POY2. The only treatment difference will take place at the time of the cataract surgery. Post-operatively, endothelial cell count will be obtained by the no-touch technology of specular microscopy at baseline as well as three months after surgery. If the study ends prematurely, the investigators do not anticipate any significant change in the care of the patient.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years of age
  • Ability to understand and sign an informed consent
  • Visually significant cataract eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye
  • Ability and commitment to follow up for 18 months after surgery
  • No other ocular pathology and no previous/concurrent surgery

排除标准

  • Any other ocular pathology that may affect best-corrected visual acuity
  • Previous or concurrent ocular surgery
  • Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
  • Patients with keratoconus or keratectasia
  • Patients who are blind on one eye

结局指标

主要结局

endothelial cell density three months after conventional CEIOL or FLACS compared to baseline

时间窗: up to 2 years

endothelial cell density will be compared at baseline and three months after a patient undergoes FLACS or Conventional CE IOL to see which technique causes less endothelial cell loss.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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