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

Completed

• Conditions: Thyroid Eye Disease
• Interventions: Other: taking periorbital selfie images using smartphones

• Registration Number: NCT05731154
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-22
• Study First Submitted: 2022-04-17
• Primary Completion: 2022-07-18
• Study Completion: 2022-07-25
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-15
• Last Update Submitted: 2023-02-15
• Study First Posted: 2023-02-16
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with thyroid eye disease

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
thyroid eye disease group	taking periorbital selfie images using smartphones	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.

Primary Outcome Measures

Name	Time	Method
Accuracy for clinical activity score (CAS) of thyroid eye disease (TED)	baseline (this study has no intervention)	Accuracy of AI solution using smartphone selfie images for CAS of TED.
Diagnostic accuracy for active thyroid eye disease	baseline (this study has no intervention)	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

Secondary Outcome Measures

Name	Time	Method
Accuracy for redness of eyelids	baseline (this study has no intervention)	Accuracy of AI solution using smartphone selfie images for redness of eyelids
Accuracy for redness of conjunctiva	baseline (this study has no intervention)	Accuracy of AI solution using smartphone selfie images for redness of conjunctiva
Accuracy for swelling of eyelids	baseline (this study has no intervention)	Accuracy of AI solution using smartphone selfie images for swelling of eyelids
Accuracy for swelling of conjunctiva	baseline (this study has no intervention)	Accuracy of AI solution using smartphone selfie images for swelling of conjunctiva
Accuracy for swelling of caruncle	baseline (this study has no intervention)	Accuracy of AI solution using smartphone selfie images for swelling of caruncle

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of