Exophthalmometry With 3D Face Scanners (EX3D)

University of Zurich (UZH)

Status: Unknown

Conditions: Graves Ophthalmopathy; Exophthalmos; Orbital Fractures; Orbital Tumor

Treatments: Device: Exophthalmos measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT04704414

CIV-19-08-029404 (Other Identifier)

BASEC-Nr. 2019-00233

10000520 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

Validation of smartphone face scanner

Experimental group

Description:

Validation of smartphone face scanner in comparison to Hertel Exophthalmometer and high-definition face scanner.

Treatment:

Device: Exophthalmos measurement