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Exophthalmometry With 3D Face Scanners (EX3D)

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ClinicalTrials.gov Identifier: NCT04704414
Recruitment Status : Recruiting
First Posted : January 11, 2021
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Konrad Peter Weber, University of Zurich

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : August 14, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04704414


Locations
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Switzerland
Ophthalmology Department, University Hospital Zurich Recruiting
Zurich, Switzerland, CH-8091
Contact: Konrad P Weber, MD    0041442555549    KONRAD.WEBER@USZ.CH   
Principal Investigator: Konrad P Weber, MD         
Sponsors and Collaborators
University of Zurich
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Responsible Party: Konrad Peter Weber, Principal Investigator, University of Zurich
ClinicalTrials.gov Identifier: NCT04704414    
Other Study ID Numbers: BASEC-Nr. 2019-00233
CIV-19-08-029404 ( Other Identifier: EUDAMED )
10000520 ( Other Identifier: Swissmedic )
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Konrad Peter Weber, University of Zurich:
Hertel exophthalmometer
exophthalmos
face scanner
smartphone
Additional relevant MeSH terms:
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Orbital Fractures
Eye Diseases
Graves Ophthalmopathy
Exophthalmos
Eye Diseases, Hereditary
Graves Disease
Orbital Diseases
Genetic Diseases, Inborn
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures
Fractures, Bone
Wounds and Injuries