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临床试验/NCT04711395
NCT04711395Unknown不适用

The Application of Lens Dysfunction Index (DLI) in the Timing of Age-related Cataract Surgery

Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Dysfunctional lens index

研究概览

简要总结

Before cataract surgery, subjects in the observation group used iTrace ocular aberration analyzer(itracey Technologies)and IOL-Master 700 biometer to measure the preoperative DLI(Dysfunctional lens index) and SS-OCT image of the lens, and The researchers used the anterior segment slit lamp to take photos of the anterior segment of the subject's lens in a state of dilated pupils .and self-scoring of the preoperative visual quality assessment scale. Healthy subjects in the control group also need to complete the above inspections. After that, three experienced cataract specialist surgeons combined the preoperative optometry data of each subject, the photos of the LOCS III anterior segment and the Catquest-9SF questionnaire score to determine whether each subjects should undergo cataract surgery. The subjects were divided into cataract surgery group and non-surgical group. Finally, statistically study the correlation between the DLI index and the degree of lens opacity that has been collected, and use the ROC curve to calculate the DLI as the best cut-off point of DLI to distinguish whether to perform cataract surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Over 40 years old
  • Healthy volunteers with no history of systemic or ocular diseases
  • patients with simple age-related cataracts without other ocular diseases
  • those who can communicate with the tester at a normal level
  • those who can express their own ideas independently

排除标准

  • irregular corneal astigmatism
  • corneal opacity
  • corneal scars
  • corneal dystrophy
  • shallow of anterior chamber
  • retinal abnormalities
  • history of eye surgery or laser treatment
  • pupil diameter less than 4.00mm in a dark environment
  • subjects who did not cooperate well during the examination

结局指标

主要结局

Dysfunctional lens index

时间窗: 2021.01-2021.02

iTrace ocular aberration analyzer(itracey Technologies) to measure the preoperative DLI(Dysfunctional lens index)

次要结局

  • SS-OCT image of the lens(2021.01-2021.02)

研究者

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

Yune Zhao

Deputy Dean

Wenzhou Medical University

研究点 (1)

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