Exophthalmometry With 3D Face Scanners

NCT04704414 | Unknown

• 3 other identifiers: BASEC-Nr. 2019-00233CIV-19-08-02940410000520
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Exophthalmos; Graves Ophthalmopathy; Orbital Tumor; Orbital Fractures

Keywords

Hertel exophthalmometer; exophthalmos; face scanner; smartphone

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  On average 3 months

Study Arms (1)

Validation of smartphone face scanner

EXPERIMENTAL

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

Device: Exophthalmos measurement

Interventions

Exophthalmos measurement DEVICE

Exophthalmos measurement with iPhone 11 vs Artec Space Spider 3D Scanner vs Hertel Exophthalmometer.

Validation of smartphone face scanner

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Ophthalmology Department, University Hospital Zurich

Zurich, CH-8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Exophthalmos; Graves Ophthalmopathy; Orbital Neoplasms; Orbital Fractures

Condition Hierarchy (Ancestors)

Orbital Diseases; Eye Diseases; Eye Diseases, Hereditary; Graves Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Eye Neoplasms; Bone Diseases; Musculoskeletal Diseases; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinding of the operators of Hertel exophthalmometer for previous measurement results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: * 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

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 11, 2021
• Study Start: August 14, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

CH (1)