Development of an AI Solution to Evaluate Clinical Activity of TAO Using Periocular Images Taken by Smartphones in Patients With Thyroid Dysfunction

NCT05731154 | Completed DMC

• 1 other identifier: B-2110-715-304
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to develop an AI solution to evaluate clinical activity score (CAS) of thyroid associated orbitopathy (TAO) using periocular selfie images taken by smartphones in patients with thyroid dysfunction. An AI solution to evaluate CAS in TAO was developed in previous retrospective study using periorbital digital images taken by DSLR camera in the studio. This AI solution will be adjusted to show its best performance with periocular selfie images taken by smartphones.

Conditions

Thyroid Eye Disease

Keywords

thyroid eye disease; artificial intelligence; machine learning; smartphone

Outcome Measures

Primary Outcomes (2)

• Accuracy for clinical activity score (CAS) of thyroid eye disease (TED)

  Accuracy of AI solution using smartphone selfie images for CAS of TED.

  baseline (this study has no intervention)

• Diagnostic accuracy for active thyroid eye disease

  Accuracy of AI solution using smartphone selfie images for active thyroid eye disease (TED) which is defined as 3 or more of clinical activity score

  baseline (this study has no intervention)

Secondary Outcomes (5)

• Accuracy for redness of eyelids

  baseline (this study has no intervention)

• Accuracy for redness of conjunctiva

  baseline (this study has no intervention)

• Accuracy for swelling of eyelids

  baseline (this study has no intervention)

• Accuracy for swelling of conjunctiva

  baseline (this study has no intervention)

• Accuracy for swelling of caruncle

  baseline (this study has no intervention)

Study Arms (1)

thyroid eye disease group

Patients who were diagnosed as thyroid eye disease. Periorbital images are taken by DSLR camera in the studio. Periorbital selfie images are taken by the patients with 6 smartphones including various camera modules. CAS of TAO is evaluated by 3 ophthalmologists based on the periorbital digital images taken by DSLR camera and symptoms.

Other: taking periorbital selfie images using smartphones

Interventions

taking periorbital selfie images using smartphones OTHER

taking periorbital selfie images using smartphones

thyroid eye disease group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is conducted to develop AI solution using smartphone selfie images. Therefore, the number of subjects for this study was calculated as 200, the maximum number of patients with thyroid eye disease that can be prospectively recruited during the study period.

You may qualify if:

• Patients with thyroid eye disease

You may not qualify if:

• Patients who have prior facial anomaly or surgery
• Patients who cannot use smartphone camera app

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• THYROSCOPE INC.: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Namju Kim, MD, PhD.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: February 16, 2023
• Study Start: December 22, 2021
• Primary Completion: July 18, 2022
• Study Completion: July 25, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)