Comparison of the New Elisar Zest Algorithm with Swedish Interactive Thresholding Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- To establish a correlation between Elisar and Humphrey visual field analyzer. If both the devices correlate well, Elisar can be used in place of Humphrey due its portable nature.
研究概览
简要总结
Protocol SummaryThe purpose of our study is to compare the threshold values of Elisar Visual Field Analyzer with Humphrey Visual Field Analyzer.
Study design: Cross-sectional study.
Inclusion criteria:
-
The best corrected visual acuity should be 6/6 for age <55 years and 6/9 or better for age >55 years.
-
Cup disc ratio less than 0.5 (intraocular difference of 0.2 mm)
â— IOP <21 mmHg (intraocular difference less than 3 mmHg).
Exclusion criteria:
- Fixation losses, false positive and false negative > 20% will be excluded from the study.
Methodology:
1. A comprehensive ophthalmological examination will be performed which includes detailed ocular and medical history, visual acuity, intraocular pressure (IOP), Vertical cup-disc ratio assessment with OCT
- Only one eye of a subject will be taken for the study.
3. Elisar zest 30-2 and Humphrey’s SITA standard will be done.
Analysis: The threshold values from Elisar zest 30-2 will be compared with the Humphrey Field Analyzer’s SITA standard 30-2 using sectors wise correlation coefficients. The mean sensitivity values of both the devices will be taken to plot the Bland Altman plots.
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
- •Inclusion criteria: 1.The best corrected visual acuity should be 6/6 for age <55 years and 6/9 or better for age >55 years.
- •2.Cup disc ratio less than 0.5 (intraocular difference of 0.2 mm) 3.IOP <21 mmHg (intraocular difference less than 3 mmHg).
排除标准
- •Exclusion criteria: Fixation losses, false positive and false negative > 20% will be excluded from the study.
结局指标
主要结局
To establish a correlation between Elisar and Humphrey visual field analyzer. If both the devices correlate well, Elisar can be used in place of Humphrey due its portable nature.
时间窗: 30 days
次要结局
- Glaucoma can be picked up at the early stage due to its affordability and portable nature.(6 months)