EX3D: Exophthalmometry With 3D Face Scanners

Sponsor

University of Zurich (Other)

Overall Status

Recruiting

CT.gov ID

NCT04704414

Collaborator

(none)

180

Enrollment

Location

Arm

40.6

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Exophthalmos Graves Ophthalmopathy Orbital Tumor Orbital Fractures	Device: Exophthalmos measurement	N/A

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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 interventionAccuracy 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)

Masking Description:

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

Primary Purpose:

Diagnostic

Official Title:

Exophthalmometry With 3D Face Scanners

Actual Study Start Date :

Aug 14, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Validation of smartphone face scanner

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

Device: Exophthalmos measurement

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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