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Exophthalmometry With 3D Face Scanners (EX3D)

Primary Purpose

Exophthalmos, Graves Ophthalmopathy, Orbital Tumor

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Exophthalmos measurement
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Exophthalmos focused on measuring Hertel exophthalmometer, exophthalmos, face scanner, smartphone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Ophthalmology Department, University Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Validation of smartphone face scanner

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
Inter-operator reliability of the smartphone face scanner
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
Measurements (measured in mm for each eye) with the smartphone face scanner before and after exophthalmos-changing treatment

Secondary Outcome Measures

Full Information

First Posted
January 6, 2021
Last Updated
January 10, 2021
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT04704414
Brief Title
Exophthalmometry With 3D Face Scanners
Acronym
EX3D
Official Title
Exophthalmometry With 3D Face Scanners
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 14, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exophthalmos, Graves Ophthalmopathy, Orbital Tumor, Orbital Fractures
Keywords
Hertel exophthalmometer, exophthalmos, face scanner, smartphone

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Validation of smartphone face scanner
Arm Type
Experimental
Arm Description
Validation of smartphone face scanner in comparison to Hertel Exophthalmometer and high-definition face scanner.
Intervention Type
Device
Intervention Name(s)
Exophthalmos measurement
Intervention Description
Exophthalmos measurement with iPhone 11 vs Artec Space Spider 3D Scanner vs Hertel Exophthalmometer.
Primary Outcome Measure Information:
Title
Accuracy of the smartphone face scanner
Description
Accuracy of iPhone exophthalmos measurements (measured in mm for each eye) compared to measure with 3D face scanner and Hertel Exophthalmometer
Time Frame
On average 2 weeks
Title
Test-retest-reliability of the smartphone face scanner
Description
Repeated measures (measured in mm for each eye) of the same subjects with iPhone 11, Hertel Exophthalmometer and 3D face scanner
Time Frame
On average 2 weeks
Title
Inter-operator reliability of the smartphone face scanner
Description
Measurement (measured in mm for each eye) of the same patients by 3 different operators
Time Frame
On average 2 weeks
Title
Smartphone face scanner measures before and after treatment with the smartphone face scanner
Description
Measurements (measured in mm for each eye) with the smartphone face scanner before and after exophthalmos-changing treatment
Time Frame
On average 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Ophthalmology Department, University Hospital Zurich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konrad P Weber, MD
Phone
0041442555549
Email
KONRAD.WEBER@USZ.CH
First Name & Middle Initial & Last Name & Degree
Konrad P Weber, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Exophthalmometry With 3D Face Scanners

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