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

Thyroid Eye Disease Clinical Trial

Official title:

Development of an Artificial Intelligence Solution to Evaluate Clinical Activity of Thyroid Associated Orbitopathy Using Periocular Selfie Images Taken by Smartphones in Patients With Thyroid Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05731154
• Other study ID #: B-2110-715-304
• Status: Completed
• Start date: December 22, 2021
• Est. completion date: July 25, 2022

Study information

• Verified date: February 2023
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 25, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients with thyroid eye disease

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid Eye Disease

Intervention

Other:
• taking periorbital selfie images using smartphones
taking periorbital selfie images using smartphones

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Thyroscope Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Accuracy for redness of eyelids	Accuracy of AI solution using smartphone selfie images for redness of eyelids	baseline (this study has no intervention)
Secondary	Accuracy for redness of conjunctiva	Accuracy of AI solution using smartphone selfie images for redness of conjunctiva	baseline (this study has no intervention)
Secondary	Accuracy for swelling of eyelids	Accuracy of AI solution using smartphone selfie images for swelling of eyelids	baseline (this study has no intervention)
Secondary	Accuracy for swelling of conjunctiva	Accuracy of AI solution using smartphone selfie images for swelling of conjunctiva	baseline (this study has no intervention)
Secondary	Accuracy for swelling of caruncle	Accuracy of AI solution using smartphone selfie images for swelling of caruncle	baseline (this study has no intervention)