Effect of Exposure to Computer Simulated Visual Field Testing on Variability and Reliability of Test Results: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The absolute value of the difference in mean deviation of the first and second visual field exam
研究概览
简要总结
Unreliability and visual field variability is a known problem with automated perimetry in both developing and developed country settings. This study will look at the effects of a computer program that allows new patients to practice the visual field exam before taking the actual exam. Our hypothesis is that the intervention group will have less variability as measured by mean deviation between exams and greater reliability as measured by the standard unreliability indexes of false positive rate, false negative rate, and fixation losses.
详细描述
3 study visits. Visit 1: Baseline visit for consent, getting baseline data and finally randomizing the patient. Those randomized to intervention get their first session of simulated visual field (2 per eye) on a regular computer for training purposes.
Visit 2: 1 to 2 days after baseline. The intervention group gets 1 practice test per eye. Then both groups get a regular automated visual field Visit 3: 1 to 2 weeks after baseline. The intervention group gets 1 practice test per eye. Then both groups get a regular automated visual field.
Study Ends, patient gets seen by the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or greater
- •Referred to the glaucoma clinic for examination due to suspected glaucoma or glaucoma diagnosis
- •No more than 1 automated visual field test within the last 4 years
排除标准
- •patients who cannot remain seated for 10 minutes
- •patients with neck problems that prevent them from using the field analyzer properly
结局指标
主要结局
The absolute value of the difference in mean deviation of the first and second visual field exam
时间窗: Visual field exams obtained 1 to 2 weeks apart
次要结局
- Difference in the absolute number of altered points in the visual field with a total deviation below the 0.5 percentile(Visual field exams obtained 1 to 2 weeks apart)
- Difference in the percentage of false positives, false negatives, and fixation losses at the first and second exam between control and intervention group(Visual field exams obtained 1 to 2 weeks apart)
- Difference in the time required to complete the first and second exam(Visual field exams obtained 1 to 2 weeks apart)
- Difference in the proportion of unreliable visual fields at the first and second exam between control and intervention groups(Visual field exams obtained 1 to 2 weeks apart)
研究者
Eugenio A. Maul
Investigator
Oftalmologia Hospital Sotero del Rio