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临床试验/NCT06707740
NCT06707740进行中(未招募)不适用

Comparison of the Effect of Capsular Bend on the Rotational Stability Between Two Toric Intraocular Lenses

Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
68
试验地点
1
主要终点
IOL rotation degree

研究概览

简要总结

(1) To compare the difference of rotational stability and CBI between AcrySof IQ(SN6AT) and TECNIS(ZCU) after cataract surgery. (2) To evaluate the influence of capsular bending on the rotational stability of these two kinds of intraocular lenses.

详细描述

To compare the difference of rotational stability and CBI between AcrySof IQ(SN6AT) and TECNIS (ZCU) torus intraocular lenses implanted after cataract surgery, and analyze the influence of capsular bag bending on the rotational stability of two kinds of astigmatism correction intraocular lenses after cataract surgery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 1.The patient's age is over 18 years old. 2.Diagnosed as age-related cataract Corneal astigmatism measured before operation is > 0.75 D or predicted after operation after taking into account surgical astigmatism (SIA).
  • 3.Pupil diameter > 7 mm after mydriasis. 4.The astigmatism meridian between IOLMaster and Pentacam is the same (the meridian difference between the two instruments is within 15).
  • 5.After operation, the anterior capsule completely covered the edge of intraocular lens optical surface.
  • 6.Able to understand, cooperate and complete all follow-up.

排除标准

  • Moderate and severe dry eye
  • There is irregular corneal astigmatism.
  • Combined with other ophthalmic diseases Previous history of ophthalmic surgery.
  • The capsulorhexis is too large or eccentric, which can not cover the optical zone of intraocular lens all around, and there are intraoperative or postoperative complications.

结局指标

主要结局

IOL rotation degree

时间窗: 1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.

The difference of degrees between the actually measured Toric IOL astigmatism axes at two adjacent follow-up time points.

Toric IOL total axial deviation

时间窗: 1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.

The degree difference between the actual axial position and the target axial position of Toric IOL is different.

Capsular bend index

时间窗: 1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.

The average value of the capsular bag bending stage in different positions of IOL represents the speed of the whole capsular bag bending formation in the eye.

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

Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Wenzhou Medical University

研究点 (1)

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