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临床试验/TCTR20220602005
TCTR20220602005Unknown3 期

Efficacy of the ROCK inhibitor for corneal endothelial protection in Fuchs' endothelial corneal dystrophy after cataract surgery

THE 90TH ANNIVERSARY OF CHULALONGKORN UNIVERSITY FUND ( Ratchadaphiseksomphot Endowment Fund)0 个研究点目标入组 56 人开始时间: 2022年6月2日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
56

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
40 Years 至 90 Years(—)
性别
All

入选标准

  • 1. Age 40-90 years old
  • 2. Diagnosis of FECD with modified Krachmer grade 1-4 and visual significance cataract with eligible for phacoemulsification with intraocular lens implantation
  • 3. Central endothelial cell count > 1,000 cell/mm2
  • 4. Paracentral endothelial cell count > 1,000 cell/mm2 in all superior /inferior/nasal/temporal quadrant
  • 5. Central corneal thickness < 640 micron
  • 6. Cataract grading: nuclear hardness graded by the Emery-Little classification 1-3
  • 7. Willingness to regular follow-up as appointed

排除标准

  • 1. History of severe ocular trauma with lens subluxation
  • 2. Corneal scar
  • 3. History of corneal laser vision correction
  • 4. Use of ripasudil before enrollment in the study
  • 5. Active allergy, infection, inflammation at ocular surface
  • 6. Unstable systemic diseases: uncontrolled HT, uncontrolled DM, stroke, coronary artery disease, cerebrovascular disease, bleeding diathesis
  • 7. History of allergy to ripasudil
  • 8. Phacoemulsification with major intraoperative complication such as large posterior capsular tear or zonule dialysis more than 90 degrees

研究者

发起方
THE 90TH ANNIVERSARY OF CHULALONGKORN UNIVERSITY FUND ( Ratchadaphiseksomphot Endowment Fund)

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