A Mechanism for Measurement of Relative Afferent Pupillary Defect (RAPD) Using Machine Learning
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Pupillary measurements
研究概览
简要总结
The goal of this prospective reliability study is to test the effectiveness of a commercially available, off-the-shelf virtual reality head-mounted display (VR HMD) and machine learning (ML) algorithms in detecting Relative Afferent Pupillary Defect (RAPD) in a group of subjects with known RAPD and another group with no known RAPD.
The main questions it aims to answer are:
- Does the use of the VR HMD and ML to replace the standard of care swinging flashlight test provide a more reliable and objective pupil measurement to detect RAPD?
- Can RAPD be detected by the VR HMD and ML algorithms at an earlier stage than the standard of care swinging light test?
Participants will be asked to undergo the standard of care swinging flashlight test, have their pupils manually measured, then have the test repeated using the VR HMD and ML.
Researchers will compare the measurements taken manually, following the standard of care swinging light test and those recorded by the VR HMD and ML to help answer the above questions.
详细描述
Purpose of the Study/Objectives
The objective of this reliability study is to successfully develop a mechanism for diagnostics of Relative Afferent Pupillary Defect (RAPD) using pupil measurement values and pathologic response. The diagnostics of this test will later be compared with the traditional swinging flashlight test results. The physiological basis of the study is that the reaction of the pupils in the right and left eyes are linked. When a bright light is shone into one eye, it will lead to an equal constriction of both pupils. When the light source is removed from the eye, the pupils will enlarge equally.
Our hypothesis is difference between pupil measurement values of two eyes when the light source moves from one eye to the other is an indicator of RAPD. This reliability study is to use a commercially-available, off-the-shelf virtual reality (VR) head-mounted display (HMD) and machine learning (ML) algorithms to detect RAPD at an earlier stage with small differences in pupil measurement values. The RAPD is a critically important sign in patients with unexplained visual loss because it is an objective finding of afferent pupillary dysfunction. The research question is if the proposed use of VR and ML to replace the swinging flashlight test provides a more reliable and objective pupil measurement to detect RAPD.
Background
A relative afferent pupillary defect (RAPD) is a critically important ophthalmologic examination finding that defines a defect (lesion) in the pupil pathway on the afferent side. A RAPD is relative to the fellow eye and occurs because of the bilateral and equal innervation of the pupils in normal individuals. The RAPD manifests as a difference in pupillary light reaction between the two eyes. The test requires two eyes but only one working pupil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 85
- •60 patients with known RAPD.
- •60 patients with no known RAPD
- •May be diagnosed with a vision disorder such as glaucoma, diabetic retinopathy, unilateral or asymmetrical disease of the retina or other degenerative ocular diseases
- •Referred to study by treating eye doctor
- •Volunteered to participate in study
- •UTMB clinic patients
- •Not belonging to an identified vulnerable population
排除标准
- •Younger than 18; older than 85 years of age
- •Not a UTMB clinic patient
- •Belonging to an identified vulnerable population
- •Participants with discomfort using glasses
- •Experience discomfort using VR HMD device
- •Participants with history of congenital pupil defects, traumatic pupils
- •Those whose pupils were dilated during the standard of care examination deemed by treating eye doctor not to be eligible to participate in study
- •Participants who do not follow study directions and/or safety procedures given by investigators or lab assistants
- •Participants who do not speak English to prevent a communication error during the informed consent process
研究组 & 干预措施
Known RAPD
Participants with known RAPD will be administered the standard of care swinging light test and pupil measurements taken manually, then administered the light test using the VR HMD and ML.
干预措施: Swinging Light test (Diagnostic Test)
Known RAPD
Participants with known RAPD will be administered the standard of care swinging light test and pupil measurements taken manually, then administered the light test using the VR HMD and ML.
干预措施: Virtual Reality Head-Mounted Display (VR HMD) (Diagnostic Test)
No Known RAPD
Participants with no known RAPD will be administered the standard of care swinging light test and pupil measurements taken manually, then administered the light test using the VR HMD and ML.
干预措施: Swinging Light test (Diagnostic Test)
No Known RAPD
Participants with no known RAPD will be administered the standard of care swinging light test and pupil measurements taken manually, then administered the light test using the VR HMD and ML.
干预措施: Virtual Reality Head-Mounted Display (VR HMD) (Diagnostic Test)
结局指标
主要结局
Pupillary measurements
时间窗: Immediately following the swinging light test or VR HMD light test
Measure of pupil size in each eye, measured manually or via machine learning algorithms
次要结局
未报告次要终点