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临床试验/NCT03976791
NCT03976791
Unknown
不适用

A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision

Zhongshan Ophthalmic Center, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 294 人2019年7月1日
适应症Cataract

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Cataract
发起方
Zhongshan Ophthalmic Center, Sun Yat-sen University
入组人数
294
试验地点
1
主要终点
descemet membrane detachment(DMD)
最后更新
6年前

概览

简要总结

Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision.

The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after 2.2 mm incision phacoemulsification.

Secondary outcome: To evaluate whether the technique of enlarged internal incision can reduce other corneal complications such as corneal edema and astigmatism after 2.2 mm incision phacoemulsification.

Study Design: A prospective randomized controlled study

注册库
clinicaltrials.gov
开始日期
2019年7月1日
结束日期
2019年12月30日
最后更新
6年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

入排标准

入选标准

  • Age-related cataract patients
  • Age from 65 to 90
  • The diameter of pupil after mydriasis is more than 6 mm
  • LOCS III nuclear grade ≥4
  • Corneal endothelial cell count \> 1500 cells/mm2
  • Phacoemulsification and intraocular lens implantation are planned
  • Agree to participate in this study and sign informed consent

排除标准

  • History of ocular trauma
  • Anterior segment lesions (exfoliation syndrome, suspension ligament injury or relaxation, corneal and iris lesions, glaucoma)
  • Other ocular diseases that impair visual function, such as optic neuropathy, uveitis and ocular tumors
  • History of Ophthalmic Surgery
  • Intraoperative and Postoperative Complications

结局指标

主要结局

descemet membrane detachment(DMD)

时间窗: postoperative 1 week

DMD at the incision observed by anterior segment optical coherence tomography

研究点 (1)

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