Developing Normative Database for Elisar Visual Field Analyzer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Data that is required for running the algorithm of the visual field analyser
研究概览
简要总结
The purpose of our study is todevelop the database of normal subjects by testing 74 points using 30-2 full thresholdalgorithm of EVFA in phase 1, 68 points using 10-2 full threshold algorithm inphase II and 16 points using macular threshold in phase III of the clinicaltrial.
Description of study device:
ElisarVisual Field Analyzer (EVFA) is the Virtual Reality (VR) based perimeter withfull threshold algorithm which measures up to 30 degrees of the visual fieldwith eye tracking.
Study duration: 2 months.
Expected commencement date: 20 thAugust 2019
The expected completion date of theproject: 20 th October 2019.
Study design: A Cross sectional study.
The proposed method of statisticalanalysis:
The linear model for age effectswill be constructed for each of the locations of the 30°field. The ageslopes and the intercepts will be derived for each of the locations and fovea.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 10.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •The best-corrected visual acuity should be 6/6 for age <55 years and 6/9 or better for age >55 years.
- •Spherical equivalent of the correction should be less than or equal to +/- 5 D 3.Cup disc ratio less than 0.5 (intraocular difference of 0.2 mm) 4.IOP <21 mmHg ( intraocular difference less than 3 mmHg).
排除标准
- •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.
结局指标
主要结局
Data that is required for running the algorithm of the visual field analyser
时间窗: 60 days
次要结局
- The other subjects will be compared with this data and they can be categorised as normal or abnormal .(60 days)