Exophthalmometry With 3D Face Scanners

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Exophthalmometry With 3D Face Scanners

Conditions
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Exophthalmos, Graves Ophthalmopathy, Orbital Tumor, Orbital Fractures

Intervention / Treatment
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* Device: Exophthalmos measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Unable to sign informed consent Unable to cooperate with the examinations (hearing loss, neurological deficits)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Accuracy and precision of smartphone in comparison with 3D face scanner and Hertel exophthalmometer Test-retest reliability Inter-operator reliability Before and after exophthalmos-changing intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Validation of smartphone face scanner<br>Validation of smartphone face scanner in comparison to Hertel Exophthalmometer and high-definition face scanner. | Device: Exophthalmos measurement<br>* Exophthalmos measurement with iPhone 11 vs Artec Space Spider 3D Scanner vs Hertel Exophthalmometer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the smartphone face scanner | Accuracy of iPhone exophthalmos measurements (measured in mm for each eye) compared to measure with 3D face scanner and Hertel Exophthalmometer | On average 2 weeks | 
| Test-retest-reliability of the smartphone face scanner | Repeated measures (measured in mm for each eye) of the same subjects with iPhone 11, Hertel Exophthalmometer and 3D face scanner | On average 2 weeks | 
| Inter-operator reliability of the smartphone face scanner | Measurement (measured in mm for each eye) of the same patients by 3 different operators | On average 2 weeks | 
| Smartphone face scanner measures before and after treatment with the smartphone face scanner | Measurements (measured in mm for each eye) with the smartphone face scanner before and after exophthalmos-changing treatment | On average 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hertel exophthalmometer, exophthalmos, face scanner, smartphone