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临床试验/NCT01504607
NCT01504607已完成不适用

Corneal Endothelial Morphologic Assessment in Pediatric Cataract Surgery With IOL Implantation: Comparison of Preoperative and Early Postoperative Specular Microscopy

Iladevi Cataract and IOL Research Center0 个研究点目标入组 106 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
主要终点
Corneal endothelial morphology

研究概览

简要总结

Cataract surgery is known to cause loss of corneal endothelial cells. In adults, it is reported that anywhere between 2 to 15% loss of corneal endothelial cell density occurs following cataract surgery. However, no data is available regarding endothelial changes after cataract surgery with IOL implantation in pediatric eyes.

The aim of this study is to prospectively observe changes in endothelial cell density, coefficient of variation and hexagonality following cataract surgery with IOL implantation in pediatric eyes.

研究设计

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

入排标准

年龄范围
4 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Eyes undergoing pediatric cataract surgery with IOL implantation at Iladevi Cataract & IOL Research Center, Ahmedabad, India.
  • Children older than 4 years undergoing cataract surgery with IOL implantation were included.

排除标准

  • Exclusion criteria were as follows: eyes with traumatic or subluxated cataract and inability to get preoperative specular. Intraoperatively, sulcus fixated IOLs, and eyes with no IOL implantation were excluded.

结局指标

主要结局

Corneal endothelial morphology

时间窗: preoperatively to 3 months postoperatively

Change in corneal endothelial cell density, (CD), coefficient of variation (CV) and % of hexagonality (6A) were studied from preoperatively to 3 months postoperatively

次要结局

  • Change in central corneal thickness(preoperatively to 3 months postoperatively)

研究者

发起方
Iladevi Cataract and IOL Research Center
申办方类型
Other
责任方
Sponsor

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