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临床试验/NCT04006912
NCT04006912Unknown不适用

The Influence of Different Preoperative Decision Schemes on the Visual Quality After Toric Intraocular Lens Implantation

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Actual residual astigmatism after surgery

研究概览

简要总结

To study the Influence of Different Preoperative Decision Schemes on the Visual Quality After Toric Intraocular Lens Implantation

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
Single (Participant)

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age-related cataract (age 55-80)
  • •Corneal astigmatism is greater than 1.0D
  • •Patients who are willing to implant Toric IOL

排除标准

  • •Previous or present eye diseases, such as glaucoma, eye trauma, etc
  • •High refractive error
  • •Previous eye surgery
  • •Irregular astigmatism of the cornea

研究组 & 干预措施

Steep meridian incision design group

Active Comparator

干预措施: phacoemulsification and Toric intraocular lens implantation (Procedure)

Minimal residual theoretical astigmatism group

Experimental

干预措施: phacoemulsification and Toric intraocular lens implantation (Procedure)

结局指标

主要结局

Actual residual astigmatism after surgery

时间窗: 3 month postoperation

The actual residual astigmatism value after the operation is measured with the phoropter

Actual residual astigmatism after surgery

时间窗: 1 week postoperation

The actual residual astigmatism value after the operation is measured with the phoropter

Actual residual astigmatism after surgery

时间窗: 1 month postoperation

The actual residual astigmatism value after the operation is measured with the phoropter

次要结局

  • uncorrected distance visual acuity (UDVA)(3 month postoperation)
  • Theoretical residual astigmatism after surgery(3 month postoperation)
  • Corneal Aberrations(3 month postoperation)
  • Postoperative Totic intraocular lens rotation angle(3 month postoperation)
  • Postoperative astigmatism and astigmatism axial of cornea(3 month postoperation)
  • uncorrected distance visual acuity (UDVA)(1 week postoperation)
  • uncorrected distance visual acuity (UDVA)(1 month postoperation)
  • Theoretical residual astigmatism after surgery(1 week postoperation)
  • Corneal Aberrations(1 week postoperation)
  • Theoretical residual astigmatism after surgery(1 month postoperation)
  • Postoperative Totic intraocular lens rotation angle(1 week postoperation)
  • Postoperative Totic intraocular lens rotation angle(1 month postoperation)
  • Postoperative astigmatism and astigmatism axial of cornea(1 week postoperation)
  • Postoperative astigmatism and astigmatism axial of cornea(1 month postoperation)
  • Corneal Aberrations(1 month postoperation)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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