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临床试验/NCT04130334
NCT04130334Unknown2 期

Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN: a Clinical Trial

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
52
试验地点
1
主要终点
graft astigmatism

研究概览

简要总结

Patients with KCN who undergo cornea transplantation divided to 2 groups:

Group1: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea Group 2: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea After suture removal, best corrected visual acuity, refractive error, corneal keratometry, irregularity of corneal surface and high order aberration of two groups will compare

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with KCN who undergo DALK surgery

排除标准

  • Penetrating Keratoplasty surgery
  • Other corneal diseases
  • dystrophies
  • Corneal graft rejection

研究组 & 干预措施

horizontal meridian of donor's cornea sutured to horizontal

Active Comparator

horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea

干预措施: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea (Procedure)

horizontal meridian of donor's cornea sutured to vertical

Active Comparator

horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea

干预措施: : After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea (Procedure)

结局指标

主要结局

graft astigmatism

时间窗: 14 months

Topography

Best corrected visual acuity

时间窗: 14 months

Snellen chart

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zahra Rabbani Khah

Head of ophthalmic research center

Shahid Beheshti University of Medical Sciences

研究点 (1)

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