跳至主要内容
临床试验/NCT05657951
NCT05657951进行中(未招募)不适用

Repeatability and Reproducibility of Lens Zonule Length Measurement Using ArcScan Insight 100 Very High-frequency Digital Ultrasound

Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年8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
45
试验地点
1
主要终点
Repeatability of ArcScan Insight 100 zonule scans in normal eyes (standard deviation and coefficient of variation)

研究概览

简要总结

The purpose of this study is to evaluate the intra-examiner repeatability and inter-examiner reproducibility in lens zonule length measurements using very high-frequency (VHF) digital ultrasound (ArcScan Insight 100).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Subjects with no ocular disease except ametropia
  • Subjects will be able to understand and willing to sign an informed consent

排除标准

  • Previous ocular surgery
  • Subjects not being able to tolerate or not willing to use pilocarpine eye drops
  • Subjects has active ocular infection or inflammation
  • Subjects not being able to look steadily
  • Subjects not being able to open eyes wide in sterile saline even after topical anesthesia

结局指标

主要结局

Repeatability of ArcScan Insight 100 zonule scans in normal eyes (standard deviation and coefficient of variation)

时间窗: 1 day

First, three images will be obtained under'capsule model'using ArcScan Insight 100, and the length of zonule will be measured with built-in software by operator A. Operator B then performed the measurements using the same procedure and technique. The standard deviation and coefficient of variation of 3 repeated measurements for zonule length. will be calculated.

Reproducibility of ArcScan Insight 100 zonule scans in normal eyes

时间窗: 1 day

First, three images will be obtained under'capsule model'using ArcScan Insight 100, and the length of zonule will be measured with built-in software by operator A. Operator B then performed the measurements using the same procedure and technique. The intraclass correlation is used to evaluate the difference between operator A and operator B.

次要结局

  • Repeatability of zonule length measurement with the built-in software (the intraclass correlation)(1 month)

研究者

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

Yune Zhao

Vice president

Wenzhou Medical University

研究点 (1)

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