Clinical trial NCT04704414: Exophthalmometry With 3D Face Scanners
Official title: Exophthalmometry With 3D Face Scanners
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exophthalmos
Graves Ophthalmopathy
Orbital Tumor
Orbital Fractures
Keywords: Hertel exophthalmometer
exophthalmos
face scanner
smartphone
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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:

1. Accuracy and precision of 3D face-scanner and iPhone in comparison to Hertel Exophthalmometer.
2. Test re-test reliability in comparison to Hertel Exophthalmometer.
3. Inter-operator reliability against Hertel Exophthalmometer.
4. Patients before and after exophthalmos changing treatment.
5. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Accuracy of the smartphone face scanner
timeFrame: On average 2 weeks
measure: Test-retest-reliability of the smartphone face scanner
timeFrame: On average 2 weeks
measure: Inter-operator reliability of the smartphone face scanner
timeFrame: On average 2 weeks
measure: Smartphone face scanner measures before and after treatment with the smartphone face scanner
timeFrame: On average 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Ophthalmology Department, University Hospital Zurich
Study officials:
References: