Exophthalmometry With 3D Face Scanners

Graves Ophthalmopathy Clinical Trial

— EX3D  

Official title:

Exophthalmometry With 3D Face Scanners

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04704414
• Other study ID #: BASEC-Nr. 2019-00233
• Secondary ID: CIV-19-08-029404
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Exophthalmos
• Eye Diseases
• Graves Ophthalmopathy
• Orbital Fractures
• Orbital Tumor

Intervention

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

Locations

Country	Name	City	State
Switzerland	Ophthalmology Department, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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