跳至主要内容
临床试验/CTRI/2020/04/024647
CTRI/2020/04/024647尚未招募不适用

Comparison of threshold estimates of current version Elisar 30-2 full threshold algorithm with the updated version of Elisar 30-2 full threshold algorithm and with 30-2 full threshold algorithm of Humphrey visual field analyzer.

Dr Amar Agarwal4 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2020年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
109
试验地点
4
主要终点
To establish the equivalence between threshold estimates of updated algorithm of 30-2 Elisar AVA and the 30-2 of Humphrey visual field analyser

研究概览

简要总结

Purpose: The aim of our study is to compare the thresholdestimates of the current version of Elisar full threshold 30-2 with the updated version of full threshold 30-2 of Elisar AVATM and withfull threshold 30-2 of Humphrey visual field analyzer.

Description of the study: Cross-sectionalstudy to Comparison of threshold estimates of current version Elisar 30-2 fullthreshold             algorithm with the updated version of Elisar 30-2 full thresholdalgorithm and with 30-2 full threshold algorithm of Humphrey visual

fieldanalyzer in both a healthy group and a study group exhibiting advancedfield loss (with threshold values less than 9 dB).

Methods:

A comprehensive initial screening should bedone to confirm whether the patient met the inclusion/exclusion criteria. Thosepatients who meet the inclusion criteria will undergo trial procedures byfollowing the randomization sheet.

Analysis: Bland Altman plots and Intraclass correlation will be done to compare the results from both the devices.

研究设计

研究类型
Observational

入排标准

年龄范围
17.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •Abnormal subjects consist of both Glaucoma and other conditions with decibel values of less than 9 dB in HFA will be included in the study For controls: 2.The best-corrected visual acuity of 6/12 or better as measured with Snellen’s visual acuity char.

排除标准

  • •Patients who had undergone ocular surgeries (other than cataract surgery), patients with ocular disease, amblyopia, neurological disorders will be excluded from the study.
  • •Patients using a miotic drug will be excluded from the study.

结局指标

主要结局

To establish the equivalence between threshold estimates of updated algorithm of 30-2 Elisar AVA and the 30-2 of Humphrey visual field analyser

时间窗: 45 days

次要结局

  • To establish the equivalence between threshold estimates of updated algorithm of 30-2 Elisar AVA and the 30-2 of Humphrey visual field analyser(45 days)

研究者

发起方
Dr Amar Agarwal
申办方类型
Other [self]

研究点 (4)

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