Exophthalmometry With 3D Face Scanners
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Test-retest-reliability of the smartphone face scanner
研究概览
简要总结
This study investigates diagnostic methods to measure eyeball protrusion with a smartphone face scanner compared to the traditional Hertel exophthalmometer. The study aims to validate a new reliable, fast and convenient smartphone app to measure the protrusion of the eyeball in different diseases such as Graves' disease, orbital tumors, orbital fractures or orbital inflammation, as well as other rare diseases.
详细描述
BACKGROUND: Accurate and reproducible measures of abnormal eyeball protrusion are important for diagnosing different causes of exophthalmos, as well as following patients with Grave's orbitopathy and retroorbital tumors. The current clinical gold standards for measuring abnormal eyeball protrusion is the Hertel exophthalmometer, which is prone to reading errors and inconvenient to use.
OBJECTIVE: The purpose of the EX3D-project is to replace the historic Hertel Exophthalmometer with a state-of-the-art mobile smartphone app that every ophthalmologist can carry in his pocket.
METHODS: The investigators developed an accurate and easy to use method for measuring abnormal eyeball protrusion using the TrueDepth camera of the iPhone 11 in comparison with a high-resolution 3D scanner as a reference to compare with the Hertel Exophthalmometer.
OUTCOMES:
- Accuracy and precision of 3D face-scanner and iPhone in comparison to Hertel Exophthalmometer.
- Test re-test reliability in comparison to Hertel Exophthalmometer.
- Inter-operator reliability against Hertel Exophthalmometer.
- Patients before and after exophthalmos changing treatment.
- Applicability in daily clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Blinding of the operators of Hertel exophthalmometer for previous measurement results.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Able to cooperate with the study investigations (hearing, comprehension)
- •Exophthalmos (Grave's disease, orbital tumors, orbital inflammation, orbital fractures, rare causes (congenital, e.g. microphthalmos)
- •health controls
排除标准
- •Unable to sign informed consent
- •Unable to cooperate with the examinations (hearing loss, neurological deficits)
结局指标
主要结局
Test-retest-reliability of the smartphone face scanner
时间窗: On average 2 weeks
Repeated measures (measured in mm for each eye) of the same subjects with iPhone 11, Hertel Exophthalmometer and 3D face scanner
Accuracy of the smartphone face scanner
时间窗: On average 2 weeks
Accuracy of iPhone exophthalmos measurements (measured in mm for each eye) compared to measure with 3D face scanner and Hertel Exophthalmometer
Inter-operator reliability of the smartphone face scanner
时间窗: On average 2 weeks
Measurement (measured in mm for each eye) of the same patients by 3 different operators
Smartphone face scanner measures before and after treatment with the smartphone face scanner
时间窗: On average 3 months
Measurements (measured in mm for each eye) with the smartphone face scanner before and after exophthalmos-changing treatment
次要结局
未报告次要终点
研究者
Konrad Peter Weber
Principal Investigator
University of Zurich