Exophthalmometry With 3D Face Scanners

Last updated: January 10, 2021
Sponsor: University of Zurich
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04704414
BASEC-Nr. 2019-00233
CIV-19-08-029404
10000520
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent
  • Able to cooperate with the study investigations (hearing, comprehension)
  • Exophthalmos (Grave's disease, orbital tumors, orbital inflammation, orbitalfractures, rare causes (congenital, e.g. microphthalmos)
  • health controls

Exclusion

Exclusion Criteria:

  • Unable to sign informed consent
  • Unable to cooperate with the examinations (hearing loss, neurological deficits)

Study Design

Total Participants: 180
Study Start date:
August 14, 2019
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Ophthalmology Department, University Hospital Zurich

    Zurich, CH-8091
    Switzerland

    Active - Recruiting

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