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临床试验/NCT02810665
NCT02810665Unknown不适用

Repeatability and Concordance of Visual Acuity Level Measured With ETDRS Numeric Charts, ETDRS Landolt C Charts, and Original ETDRS Letter Visual Acuity Charts in Thai Individuals

Chiang Mai University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
180
试验地点
1
主要终点
Concordance of VA tested with ETDRS alphabet, Landolt C and numeric visual acuity charts

研究概览

简要总结

This is a cross-sectional study to determine the repeatability and concordance of visual acuity level measured with the original ETDRS letter, ETDRS Landolt C, and ETDRS numeric chart in Thai individuals.

详细描述

The ETDRS visual acuity chart has been used as a standard visual acuity measurement chart in ophthalmic clinical trials due to its proven high repeatability comparing to other visual acuity chart. However, the original ETDRS alphabet chart could not be used in every individual around the world, especially those who are non-english speakers. Landolt C chart has been a recommended chart to test visual acuity in those living in a country where English is not a common language, however, some difficulties including right-left confusion occurred when testing with the Landolt C chart, leading to the unreliable results of visual acuity measurement using the Landolt C chart. Recently, the ETDRS numeric chart was introduced by some medical equipment companies but there is limited information regarding the repeatability and concordance of the new ETDRS numeric chart comparing to the original ETDRS alphabet and Landolt C chart.

Therefore, this study aims to determine the repeatability and concordance of visual acuity level measured with the original ETDRS alphabet, the ETDRS Landolt C, and the ETDRS numeric chart. Results from this study would be able to suggest an appropriate ETDRS chart to be used in clinical studies in Thailand or other countries where English is not the native language.

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

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

入选标准

  • Thai nationality
  • More than 18 years of age
  • Educational level: at least high school
  • Able to read English alphabet

排除标准

  • 未提供

结局指标

主要结局

Concordance of VA tested with ETDRS alphabet, Landolt C and numeric visual acuity charts

时间窗: Day 1

次要结局

  • Repeatability of VA tested with ETDRS alphabet, Landolt C and numeric visual acuity charts(Day 1)
  • Differences in testing duration of VA measurement across the 3 ETDRS charts(Day 1)

研究者

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

Voraporn Chaikitmongkol

Instructor

Chiang Mai University

研究点 (1)

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