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临床试验/NCT02058394
NCT02058394Unknown不适用

Postoperative Events in Patients With and Without Retained Nuclear Fragments in the Anterior Vitreous After Routine Phacoemulsification

Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Macular edema

研究概览

简要总结

The purpose of this study is to investigate postoperative events in patients noted to have retained nuclear fragments in the anterior vitreous during routine phacoemulsification and in those who did not.

详细描述

In this study, we investigate whether presence of retained nuclear fragments in the anterior vitreous noted during uncomplicated cataract surgery is associated with higher incidence of postoperative adverse events. We will be assessing events including cystoid macular edema, iritis, elevated intraocular pressure, and retinal detachment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Routine cataract surgery with phacoemulsification

排除标准

  • Pre-existing macular edema
  • Active uveitis
  • Intraocular exclusion surgeries
  • Significant ocular trauma
  • Evidence of phacodonesis or zonular weakness .

结局指标

主要结局

Macular edema

时间窗: 1 month postoperatively

Proportion of eyes with clinical macular edema and subclinical macular edemas measured by OCT at 1 month postoperatively

次要结局

  • Intraocular inflammation(1 month postoperativley)
  • Elevated intraocular pressure(1 month postoperatively)
  • Macular Edema(3 months postoperatively)
  • Intraocular Inflammation(3 months)
  • Elevated Intraocular Pressure(1 week postoperatively)

研究者

发起方
Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC
申办方类型
Other
责任方
Principal Investigator
主要研究者

David Ritterband

MD

Ophthalmic Consultants, Corneal and Refractive Surgery Associates, PC

研究点 (1)

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