Exophthalmometry With 3D Face Scanners (EX3D)

January 10, 2021 updated by: Konrad Peter Weber, University of Zurich
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, CH-8091
        • Recruiting
        • Ophthalmology Department, University Hospital Zurich
        • Contact:
        • Principal Investigator:
          • Konrad P Weber, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the smartphone face scanner
Time Frame: 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
On average 2 weeks
Test-retest-reliability of the smartphone face scanner
Time Frame: 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
On average 2 weeks
Inter-operator reliability of the smartphone face scanner
Time Frame: On average 2 weeks
Measurement (measured in mm for each eye) of the same patients by 3 different operators
On average 2 weeks
Smartphone face scanner measures before and after treatment with the smartphone face scanner
Time Frame: On average 3 months
Measurements (measured in mm for each eye) with the smartphone face scanner before and after exophthalmos-changing treatment
On average 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 6, 2021

First Submitted That Met QC Criteria

January 8, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 10, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC-Nr. 2019-00233
  • 10000520 (Swissmedic)
  • CIV-19-08-029404 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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