Thyroid Eye DiseaseNCT05731154
Development of an AI Solution to Evaluate Clinical Activity of TAO Using Periocular Images Taken by Smartphones in Patients With Thyroid Dysfunction
An observational study of Thyroid Eye Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- taking periorbital selfie images using smartphones
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Dec 2021to 25 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with thyroid eye disease
Who cannot join
- Patients who have prior facial anomaly or surgery
- Patients who cannot use smartphone camera app
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
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
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
- Being tested
- taking periorbital selfie images using smartphones
- Keywords
- thyroid eye disease, artificial intelligence, machine learning, smartphone
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taking periorbital selfie images using smartphonesOther
taking periorbital selfie images using smartphones
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: taking periorbital selfie images using smartphones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy for clinical activity score (CAS) of thyroid eye disease (TED)
Accuracy of AI solution using smartphone selfie images for CAS of TED.
Measured: 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
Measured: baseline (this study has no intervention)
Secondary outcomes (5)
Accuracy for redness of eyelids
Accuracy of AI solution using smartphone selfie images for redness of eyelids
Measured: baseline (this study has no intervention)
Accuracy for redness of conjunctiva
Accuracy of AI solution using smartphone selfie images for redness of conjunctiva
Measured: baseline (this study has no intervention)
Accuracy for swelling of eyelids
Accuracy of AI solution using smartphone selfie images for swelling of eyelids
Measured: baseline (this study has no intervention)
Accuracy for swelling of conjunctiva
Accuracy of AI solution using smartphone selfie images for swelling of conjunctiva
Measured: baseline (this study has no intervention)
Accuracy for swelling of caruncle
Accuracy of AI solution using smartphone selfie images for swelling of caruncle
Measured: baseline (this study has no intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start22 Dec 2021
- Primary completion18 Jul 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- THYROSCOPE INC.
- Responsible party
- Principal investigator, Namju Kim, Seoul National University Bundang Hospital
- Investigators
- Namju Kim, MD, PhD., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731154
- Sponsor's protocol ID
- B-2110-715-304
- Status last verified
- Feb 2023
- First submitted
- 17 Apr 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05731154
- Acronym / sponsor ID
- B-2110-715-304
- Conditions
- Thyroid Eye Disease
- Keywords
- thyroid eye disease, artificial intelligence, machine learning, smartphone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- THYROSCOPE INC.
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thyroid eye disease group | – | Other: taking periorbital selfie images using smartphonesPatients 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with thyroid eye disease
Key exclusion criteria (2 listed)
- Patients who have prior facial anomaly or surgery
- Patients who cannot use smartphone camera app
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taking periorbital selfie images using smartphonestaking periorbital selfie images using smartphones | Other | thyroid eye disease group |
Primary outcome
Accuracy for clinical activity score (CAS) of thyroid eye disease (TED)
Time frame: 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
Time frame: 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
5 secondary outcomes
Accuracy for redness of eyelids
Time frame: baseline (this study has no intervention)
Accuracy for redness of conjunctiva
Time frame: baseline (this study has no intervention)
Accuracy for swelling of eyelids
Time frame: baseline (this study has no intervention)
Accuracy for swelling of conjunctiva
Time frame: baseline (this study has no intervention)
Accuracy for swelling of caruncle
Time frame: baseline (this study has no intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No. IPD will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Namju Kim, MD, PhD. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Eye Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy for clinical activity score (CAS) of thyroid eye disease (TED) (time frame: baseline (this study has no intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.