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CompletedNCT05731154Updated Feb 16, 2023

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 in Thyroid Eye Disease, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-02-16.

Sponsored by Seoul National University Bundang Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
100
Ages
19 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Thyroid Eye Disease

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Keywords

  • thyroid eye disease
  • artificial intelligence
  • machine learning
  • smartphone
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In context

Graves Ophthalmopathy

198 studies on the registry are indexed under Graves Ophthalmopathy; 60 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 43 observational studies indexed under Graves Ophthalmopathy.

Browse Graves Ophthalmopathy studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.

Browse Seoul National University Bundang Hospital studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with thyroid eye disease

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Othertaking periorbital selfie images using smartphones

    taking periorbital selfie images using smartphones

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What researchers measure

Primary outcomes

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

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

    Time frame: baseline (this study has no intervention)

  2. 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

    Time frame: baseline (this study has no intervention)

Secondary outcomes

  1. Accuracy for redness of eyelids

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

    Time frame: baseline (this study has no intervention)

  2. Accuracy for redness of conjunctiva

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

    Time frame: baseline (this study has no intervention)

  3. Accuracy for swelling of eyelids

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

    Time frame: baseline (this study has no intervention)

  4. Accuracy for swelling of conjunctiva

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

    Time frame: baseline (this study has no intervention)

  5. Accuracy for swelling of caruncle

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

    Time frame: baseline (this study has no intervention)

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Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 13620, South Korea
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References and documents

Individual participant data

Plan to share: No — IPD will not be shared.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2021 to primary completion in Jul 2022, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2022
First posted
Feb 16, 2023
StartActual
Dec 22, 2021
Primary completionActual
Jul 18, 2022
CompletionActual
Jul 25, 2022
Last update
Feb 16, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05731154
Lead sponsor
Seoul National University Bundang Hospital
Collaborators
THYROSCOPE INC.
Responsible party
Namju Kim (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Feb 16, 2023
Start date
Dec 22, 2021
Primary completion
Jul 18, 2022
Completion
Jul 25, 2022
Last update
Feb 16, 2023

Study contacts

Namju Kim, MD, PhD.
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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