Exophthalmometry With 3D Face Scanners

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-14

Study Completion Date

2022-12-31

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.

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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:

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.

Conditions

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Exophthalmos Graves Ophthalmopathy Orbital Tumor Orbital Fractures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

* 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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Blinding of the operators of Hertel exophthalmometer for previous measurement results.

Study Groups

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Validation of smartphone face scanner

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

Group Type EXPERIMENTAL

Exophthalmos measurement

Intervention Type DEVICE

Exophthalmos measurement with iPhone 11 vs Artec Space Spider 3D Scanner vs Hertel Exophthalmometer.

Interventions

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Exophthalmos measurement

Exophthalmos measurement with iPhone 11 vs Artec Space Spider 3D Scanner vs Hertel Exophthalmometer.

Intervention Type DEVICE

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