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

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05731154
• Collaborator: Thyroscope Inc. (Other)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 14.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Eye Disease	Other: taking periorbital selfie images using smartphones

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• 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
• Actual Study Start Date: Dec 22, 2021
• Actual Primary Completion Date: Jul 18, 2022
• Actual Study Completion Date: Jul 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
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; taking periorbital selfie images using smartphones

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. Accuracy for redness of eyelids [baseline (this study has no intervention)]

   Accuracy of AI solution using smartphone selfie images for redness of eyelids

2. Accuracy for redness of conjunctiva [baseline (this study has no intervention)]

   Accuracy of AI solution using smartphone selfie images for redness of conjunctiva

3. Accuracy for swelling of eyelids [baseline (this study has no intervention)]

   Accuracy of AI solution using smartphone selfie images for swelling of eyelids

4. Accuracy for swelling of conjunctiva [baseline (this study has no intervention)]

   Accuracy of AI solution using smartphone selfie images for swelling of conjunctiva

5. Accuracy for swelling of caruncle [baseline (this study has no intervention)]

   Accuracy of AI solution using smartphone selfie images for swelling of caruncle

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with thyroid eye disease

Exclusion Criteria:

• Patients who have prior facial anomaly or surgery

• Patients who cannot use smartphone camera app

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	13620

Sponsors and Collaborators

• Seoul National University Bundang Hospital
• Thyroscope Inc.

Investigators

• Principal Investigator: Namju Kim, MD, PhD., Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Namju Kim, Professor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT05731154
• Other Study ID Numbers: B-2110-715-304
• First Posted: Feb 16, 2023
• Last Update Posted: Feb 16, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Namju Kim, Professor, Seoul National University Bundang Hospital: thyroid eye disease; artificial intelligence; machine learning; smartphone
• Additional relevant MeSH terms: Eye Diseases; Graves Ophthalmopathy; Thyroid Diseases

Study Results

No Results Posted as of Feb 16, 2023