Properties of perimetric threshold estimates from Full Threshold, Elisar ZEST, and Elisar Fast strategies.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- This will evaluate the Full threshold, Elisar Zest, Elisar fast and Elisar Screening. This will give a knowledge on how accurate the above strategies are.
研究概览
简要总结
Introduction: Elisar’s Visual field Analyser is a portable device that can be used to perform perimetry. The stimulus intensity starts with the value obtained from a normal population. From the patient’s response, a new curve is obtained. The probability curve obtained from the normative data and the patient’s response will give a new probability curve
Methods:
Twenty healthy volunteers and fifty glaucoma patients will be recruited from the Dr. Agarwal’s eye hospitals, Tirunelveli.
Trial Sequence:1. Full threshold strategy( 4 times), Elisar zest ( 4 times), Elisar fast ( 4 times),Elisar screening. (2 times).
Analysis:
Variability will be measured as a function of ·Age, Sensitivity , Eccentricity, Diagnosis( glaucoma/ normal), The rate of false negative,The rate of fixation loss,The rate of false positive.Single estimate of each strategy (Elisar ZEST, Elisar FAST) will be compared with the mean of three full threshold examinations. This will avoid the statistical artifact that will arise due to the regression to the mean effect.Sensitivity and specificity of the screening test will be calculated against the result of full threshold test’s Glaucoma Hemi field Test (GHT) as normal or outside the normal limits.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •The best-corrected visual acuity should be 6/6 or better.
- •Spherical equivalent of the refraction should be less than or equal to 5D.
排除标准
- •Fixation losses, false-positive and false-negative greater than 20% 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
This will evaluate the Full threshold, Elisar Zest, Elisar fast and Elisar Screening. This will give a knowledge on how accurate the above strategies are.
时间窗: 90 days
次要结局
- Repeatability of each strategy will also be calculated.(90 days)