Exophthalmometry With 3D Face Scanners (EX3D)
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|ClinicalTrials.gov Identifier: NCT04704414|
Recruitment Status : Recruiting
First Posted : January 11, 2021
Last Update Posted : January 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Exophthalmos Graves Ophthalmopathy Orbital Tumor Orbital Fractures||Device: Exophthalmos measurement||Not Applicable|
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.
- 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.
BROADER IMPACT: The invention makes exophthalmometry quick, easy and objective. A mobile smartphone application would replace measurements with the traditional Hertel Exophthalmometer, which are cumbersome, prone to reading errors and have a poor inter-rater reliability as well as test-retest reliability.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
|Masking:||None (Open Label)|
|Masking Description:||Blinding of the operators of Hertel exophthalmometer for previous measurement results.|
|Official Title:||Exophthalmometry With 3D Face Scanners|
|Actual Study Start Date :||August 14, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Validation of smartphone face scanner
Validation of smartphone face scanner in comparison to Hertel Exophthalmometer and high-definition face scanner.
Device: Exophthalmos measurement
Exophthalmos measurement with iPhone 11 vs Artec Space Spider 3D Scanner vs Hertel Exophthalmometer.
- Accuracy of the smartphone face scanner [ Time Frame: 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
- Test-retest-reliability of the smartphone face scanner [ Time Frame: 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
- Inter-operator reliability of the smartphone face scanner [ Time Frame: 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 [ Time Frame: On average 3 months ]Measurements (measured in mm for each eye) with the smartphone face scanner before and after exophthalmos-changing treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04704414
|Ophthalmology Department, University Hospital Zurich||Recruiting|
|Zurich, Switzerland, CH-8091|
|Contact: Konrad P Weber, MD 0041442555549 KONRAD.WEBER@USZ.CH|
|Principal Investigator: Konrad P Weber, MD|