Comparison of the New Elisar Fast Algorithm with Swedish Interactive thresholding Algorithm fast
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 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 Summary The purpose of our study is to compare the Elisar Visual Field Analyzer with Humphrey Visual Field Analyzer.
Description of the study device
Elisar Visual Field Analyzer (EVFA) is the Virtual Reality (VR) based perimeter which measures up to 30 degrees of the visual field with eye tracking.
Study duration: 15 days.
Study design: A 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.
2.Cup disc ratio less than 0.5 (intraocular difference of 0.2 mm)
â— 3.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
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Only one eye of a subject will be taken for the study.
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Elisar fast 30-2 and Humphrey’s SITA fast will be done.
Analysis: The threshold values from Elisar fast 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
- •Controls: 1.Cup disc ratio less than 0.5 (intraocular difference of 0.2 mm) 2.IOP <21 mmHg (intraocular difference less than 3 mmHg)(10).
- •3.The normal result of Glaucoma Hemifield test in HFA 30-2 SITA fast Glaucoma and non-glaucomatous field loss:
- •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 a cup-disc ratio less than more than 0.
- •2.A positive report of the SITA standard with Humphrey visual field analyzer.
- •The best corrected visual acuity should be better than or equal to 6/
- •Spherical correction should be < 5 D, Cylindrical correction should be < 3 D.
排除标准
- •Exclusion criteria:
- •Fixation losses, false positive and false negative > 20% will be excluded from the study.
- •The reports with significant lid artifact will be excluded from the study.
- •The lid artifact is defined as the density of the defect greater than or equal to 11 decibels (dB) for a single test location or greater than or equal to 7 dB for two adjacent test locations according to the pattern deviation from age-corrected normal values.
- •Second, the defect must involve loci between 20° and 30°.
- •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 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: 15 days
次要结局
- Glaucoma can be picked up at an early stage due to its affordability and portable nature.(6 months)