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临床试验/CTRI/2021/11/037900
CTRI/2021/11/037900招募中不适用

A Novel Contrast Sensitivity Chart At Various Levels Of Visual Acuity- Construction & Validation

Ms Namratha1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2021年11月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
54
试验地点
1
主要终点
New Contrast sensitivity chart with varying visual acuity

研究概览

简要总结

This is a Prospective exploratory study which aims to construct and validate a novel contrast chart with various levels of Visual Acuity.  The research study will follow by two phases. First construction of the Contrast

sensitivity chart primarily tested with flex print (Non tearable) material then with the acrylic material. The second phase for the validation of the chart.  Selection of subjects based on Inclusion Criteria. Clinical examination will be done which includes History, Vision both distance and near, Refraction, Slit lamp examination, direct ophthalmoscopy. CS with pellirobson by co-investigator 1 then CS with new chart by co- investigator 2.Validation process will be done by Accuracy, Precision, Reportable range. Accuracy by correlation with standard and newchart, comparison by Bland Altman plot. Precision Repeatability (after 5 days) and ‘F’ test for variance. Reportable range by Highest and lowest values, For normal values.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • BCVA better than or equal to 0.0logMAR, N6 Emmetropes Mild to Moderate of refractive error Myopia.
  • SER(-1.00 to -6.00D) Hyperopia.
  • SER(+1.00 to +5.00D).

排除标准

  • With Pathological conditions Media opacity Active ocular infection Amblyopia/Strabismus Post refractive surgery.

结局指标

主要结局

New Contrast sensitivity chart with varying visual acuity

时间窗: One year

次要结局

  • Contrast sensitivity of normal population with novel chart(One year)

研究者

发起方
Ms Namratha
申办方类型
Other [self]

研究点 (1)

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