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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-19-08-029404 | Other Identifier | EUDAMED | |
| 10000520 | Other Identifier | Swissmedic |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Validation of smartphone face scanner | Experimental | Validation of smartphone face scanner in comparison to Hertel Exophthalmometer and high-definition face scanner. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exophthalmos measurement | Device | Exophthalmos measurement with iPhone 11 vs Artec Space Spider 3D Scanner vs Hertel Exophthalmometer. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Department, University Hospital Zurich | Recruiting | Zurich | CH-8091 | Switzerland |
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| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D049970 | Graves Ophthalmopathy |
| D009918 | Orbital Neoplasms |
| D009917 | Orbital Fractures |
| ID | Term |
|---|---|
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
| D006111 | Graves Disease |
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Blinding of the operators of Hertel exophthalmometer for previous measurement results.
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012888 | Skull Neoplasms |
| D001859 | Bone Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005134 | Eye Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |