ExophthalmosEX3DNCT04704414
Exophthalmometry With 3D Face Scanners
A study testing Exophthalmos measurement in people with Exophthalmos and Graves Ophthalmopathy, run by University of Zurich at 1 site in Switzerland.
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'… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exophthalmos, Graves Ophthalmopathy, Orbital Tumor
- What is being tested?
- Exophthalmos measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Aug 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to sign informed consent
- Unable to cooperate with the examinations (hearing loss, neurological deficits)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Ophthalmology Department, University Hospital Zurich
Zurich, CH-8091
Konrad P Weber, MD, 0041442555549, KONRAD.WEBER@USZ.CH
Konrad P Weber, MD
About this study
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.
Read the 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.
- Conditions
- Exophthalmos, Graves Ophthalmopathy, Orbital Tumor, Orbital Fractures
- Being tested
- Exophthalmos measurement
- Keywords
- Hertel exophthalmometer, exophthalmos, face scanner, smartphone
- Medical subject headings
- Exophthalmos, Graves Ophthalmopathy, Orbital Neoplasms, Orbital Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exophthalmos measurementDevice
Exophthalmos measurement with iPhone 11 vs Artec Space Spider 3D Scanner vs Hertel Exophthalmometer.
| Study group | Role | What they receive |
|---|---|---|
| Validation of smartphone face scanner | Experimental | Validation of smartphone face scanner in comparison to Hertel Exophthalmometer and high-definition face scanner. Receives: Device: Exophthalmos measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: On average 2 weeks
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
Measured: On average 2 weeks
Inter-operator reliability of the smartphone face scanner
Measurement (measured in mm for each eye) of the same patients by 3 different operators
Measured: On average 2 weeks
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
Measured: On average 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start14 Aug 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExophthalmosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konrad Peter Weber, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704414
- Sponsor's protocol ID
- BASEC-Nr. 2019-00233
- Other IDs
- CIV-19-08-029404, 10000520
- Acronym
- EX3D
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exophthalmometry With 3D Face Scanners
- ClinicalTrials.gov ID
- NCT04704414
- Acronym / sponsor ID
- EX3D / BASEC-Nr. 2019-00233
- Conditions
- Exophthalmos, Graves Ophthalmopathy, Orbital Tumor, Orbital Fractures
- Keywords
- Hertel exophthalmometer, exophthalmos, face scanner, smartphone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Validation of smartphone face scanner | Experimental | Device: Exophthalmos measurementValidation of smartphone face scanner in comparison to Hertel Exophthalmometer and high-definition face scanner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to sign informed consent
- Unable to cooperate with the examinations (hearing loss, neurological deficits)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exophthalmos measurementExophthalmos measurement with iPhone 11 vs Artec Space Spider 3D Scanner vs Hertel Exophthalmometer. | Device | Validation of smartphone face scanner |
Primary outcome
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ophthalmology Department, University Hospital Zurich
Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exophthalmos measurement in people with Exophthalmos and Graves Ophthalmopathy, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the smartphone face scanner (time frame: On average 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.