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临床试验/NCT04418986
NCT04418986已完成4 期

Incisional Correction of Corneal Astigmatism During Phacoemulsification

Al-Rasheed University College2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Mean surgically induced astigmatism

研究概览

简要总结

Today, cataract surgery is regarded as refractive surgery, mainly aiming emmetropia, and this makes eliminating corneal astigmatism is critical. Corneal astigmatism of more than 1 diopter has been reported in up to 45% of the cataract surgery candidates.

It is possible to reduce pre-existing corneal astigmatism by creating a clear corneal incision at the steep meridian of the cornea, however; creating a small incision can correct the only astigmatism up to 1 Diopter, and sometimes this method may not be easy to perform due to the location of steep meridian like the difficulty while creating a superonasal or inferonasal incision at the left eye. This approach is usually sufficient for correcting astigmatism less than 1 D in most eyes. An opposite side clear corneal incision (OCCI) could enhance the flattening effect on the cornea.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Clear cornea
  • No history of previous ocular surgery
  • Central corneal thickness (CCT) <640

排除标准

  • Irregular corneal astigmatism or lenticular astigmatism
  • Corneal opacities or pathology like Fuch's endothelial dystrophy
  • Previous ocular surgeries like glaucoma surgery or PKP or pterygium excision
  • Posterior segment diseases and pathology
  • Complicated phacoemulsification

结局指标

主要结局

Mean surgically induced astigmatism

时间窗: After 1 month of surgery

Mean surgically induced astigmatism, measured by a vector-corrected method

Mean astigmatic correction

时间窗: After 1 month of surgery

Astigmatic correction change after the correction surgery

次要结局

  • Change in visual acuity(After 1 month of surgery)

研究者

发起方
Al-Rasheed University College
申办方类型
Other
责任方
Sponsor

研究点 (2)

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