Comparison of the 10-2 full threshold, 10-2 ZEST, 10-2 fast algorithm Elisar AVATM with corresponding algorithm of 10-2 of Humphrey visual field analyzer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- To establish the equivalence between threshold estimates of 10-2 Elisar AVA with the 10-2 of Humphrey visual field analyser
研究概览
简要总结
Purpose: The study aims to prove the equivalence of threshold estimates of 10-2 full threshold algorithm, 10-2 Elisar ZEST and 10-2 Elisar fast of AVATM with the corresponding algorithm of an established, industry-recognized visual field analyzer (Zeiss Humphrey Field Analyzer, or HFA).
Description of the study: Cross-sectional study to compare thethreshold estimates of 10-2 full threshold algorithm, 10-2 Elisar ZEST the algorithm, 10-2 Elisar fast algorithm of AVATM with thecorresponding algorithm of Zeiss Humphrey visual field analyzer (HFA)in both a the healthy control group and a study group exhibiting field loss (secondary toglaucoma or non-glaucoma conditions).
Study duration: 45 days
Study design: A cross-sectional study.
Inclusion criteria: Best-corrected visual acuity better than 6/12; Cup disc ratio less than 0.5 for controls.
Best-corrected visual acuity better than 6/12; cup disc ratio more than 0.5 for glaucoma.
Exclusion criteria: Patients who are under miotic therapy will be excluded from the study.
Methodology: The control group will undergo dilationfollowed by random execution of both 10-2 full threshold of AVATM and10-2 full threshold of HFA trial procedures. The glaucoma group and the other conditions group will undergogonioscopy and applanation tonometry; patients with open angles will be dilatedprior to random execution of AVATM and HFA trial procedures. ForPatients with closed angles the trial will be done with undilated pupils.
Analysis: ICC and Bland Altman plots will be made to compare the threshold estimates of 10-2 of Elisar AVATM and the 10-2 of Humphrey visual field analyzer
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
- •Controls:
- •Cup disc ratio of less than 0.
- •IOP less than 20 mm Hg
- •Visual acuity better than 6/12.
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 10-2 Elisar AVA with the 10-2 of Humphrey visual field analyser
时间窗: 45 days
次要结局
- To establish the equivalence in mean deviation and pattern standard deviation between threshold estimates of 10-2 Elisar AVA with the 10-2 of Humphrey visual field analyser(45 days)