Diagnostic Ability of a New Supra-Threshold Screening Program in Elisar 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
- 160
- 试验地点
- 1
- 主要终点
- To establish the diagnostic ability of the new Elisar Screening algorithm
研究概览
简要总结
Protocol Summary:
The purpose of our study is to compare the Elisar Supra threshold algorithm with the Humphrey‘s screening algorithm.
Description of study device:
Elisar Visual Field Analyzer (EVFA) is the Virtual Reality (VR) based perimeter.
Study design: A cross sectional study.
Inclusion criteria:
Controls:
1. The best corrected visual acuity should be 6/6 for age <55 years and 6/9 or better for age >55 years.
2. Spherical correction should be < 5 D, Cylindrical correction should be < 3 D.
Glaucoma:
1. Glaucoma is defined as IOP greater than 21 mmHg or intraocular difference in IOP more than 3mmHg and Cup disc ratio more than 0.5, and the intraocular difference in cup disc ratio less than more than 0.2.
2. A positive report of the screening test with Humphrey visual field analyzer.
Exclusion criteria:
1. Fixation losses , false positive and false negative > 20% will be excluded from the study.
2. The reports with significant lid artifact will be excluded from the study.
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: 1.The best corrected visual acuity should be 6/6 for age <55 years and 6/9 or better for age >55 years.
- •2.Spherical correction should be < 5 D, Cylindrical correction should be < 3 D.
- •Glaucoma: Glaucoma is defined as the IOP greater than 21 mmHg or intraocular difference in IOP more than 3mmHg and Cup disc ratio more than 0.5, and the intraocular difference in cup disc ratio less than more than 0.2.
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 diagnostic ability of the new Elisar Screening algorithm
时间窗: 45 days
次要结局
- The glaucoma can be diagnosed at an early stage(6 months)