Thyroid Eye Disease (TED)THYROSCOPE-TEDNCT07623993
Prospective Observational Study of Smartphone-Based AI Self-Monitoring During Non-Surgical Treatment for Thyroid Eye Disease (THYROSCOPE)
An observational study of Thyroid Eye Disease (TED) and Graves Ophthalmopathy, run by THYROSCOPE INC. at 1 site in United States.
Trial summary
This prospective observational study evaluates the feasibility and clinical utility of a smartphone-based artificial intelligence (AI) self-monitoring system in adults with thyroid eye disease (TED) undergoing non-surgical treatment. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Thyroid Eye Disease (TED), Graves Ophthalmopathy, Thyroid Associated Ophthalmopathies
- What is being tested?
- Smartphone-based AI self-monitoring application (Glandy CAS/EXO/LID)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥19 years) with clinically diagnosed TED who are scheduled to initiate active non-surgical treatment at participating ophthalmology sites.
Who may be able to join
- Adults aged 19 years or older with a clinical diagnosis of thyroid eye disease (TED).
- Patients with TED scheduled to initiate active non-surgical treatment, including but not limited to intravenous methylprednisolone, oral corticosteroids, radiotherapy, or biologic therapy.
- Able to undergo baseline clinical assessment prior to initiation of the planned treatment course and expected routine follow-up evaluation during treatment, including an end-of-treatment assessment.
- Able and willing to use their own smartphone to complete the study application-guided symptom questionnaire and capture standardized frontal facial images throughout the study period.
- Willing to perform at least weekly home-based image capture and symptom reporting during the treatment course.
- Able to participate in routine in-person follow-up visits and expected to provide at least two clinic-matched assessments, including baseline and at least one post-baseline assessment.
- Voluntarily provides written informed consent to participate in the study.
Who cannot join
- Severe eyelid deformities, facial deformities, or other facial/periocular conditions that may interfere with standardized image acquisition or reliable AI-based image analysis.
- Unable to use the study application or smartphone-based image capture procedure adequately for protocol-required self-monitoring.
- Undergoing or planning to undergo surgical treatment for TED as the primary treatment modality during the study period.
- History of ocular, eyelid, or orbital surgery within 3 months prior to enrollment.
- Any medical, psychiatric, cognitive, or other condition that, in the investigator's judgment, may compromise protocol compliance, study participation, or data integrity.
- Any other condition that the investigator judges to make the patient inappropriate for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
3003 North First Street #221
San Jose, California, 95134
Jaemin Park CEO, +82-52-264-4154, jaemin.park@thyroscope.com
About this study
Official title: Prospective Observational Study of Smartphone-Based Self-Monitoring Using an Artificial Intelligence Solution During Non-Surgical Treatment for Thyroid Eye Disease
This prospective observational study evaluates the feasibility and clinical utility of a smartphone-based artificial intelligence (AI) self-monitoring system in adults with thyroid eye disease (TED) undergoing non-surgical treatment. Eligible participants will use their own smartphones and the study application (Glandy) to perform at least weekly home monitoring consisting of a symptom questionnaire (diplopia, pain on visual analog scale) and a standardized frontal facial photograph. AI-derived outputs (Glandy CAS, Glandy EXO, Glandy LID) obtained at routine clinic visits will be compared with standard clinician assessments (CAS total score, Hertel exophthalmometry, MRD1/MRD2). AI outputs will not be used for real-time clinical decision-making during the study.
Read the detailed description
Thyroid eye disease (TED) is an autoimmune inflammatory disorder most commonly associated with Graves' disease. Clinical manifestations include conjunctival injection, eyelid swelling, eyelid retraction, proptosis, diplopia, and altered ocular appearance. TED typically progresses through an active inflammatory phase of approximately 6-12 months before transitioning to a relatively inactive phase, although interval worsening may occur. Because treatment response can change dynamically, timely assessment of disease activity and severity is important for monitoring.
In current practice, TED activity and severity are primarily assessed during in-person visits using the Clinical Activity Score (CAS), Hertel exophthalmometry, and eyelid measurements (MRD1/MRD2). These assessments are episodic and may not capture interval change between visits.
Recent advances in AI have enabled image-based quantification of TED-related features from facial or periocular photographs. The AI-based monitoring system evaluated here has three analytic components: Glandy CAS (CAS-related outputs from photographs + symptom input), Glandy EXO (image-based exophthalmometric estimate), and Glandy LID (eyelid-related parameters including MRD measurements).
This prospective observational study will enroll approximately 200 adults with TED scheduled to initiate non-surgical treatment (intravenous methylprednisolone, oral corticosteroids, radiotherapy, or biologic therapy). Participants will perform at least weekly home-based self-monitoring (symptom entry + standardized frontal facial image) using their own smartphones and the study application. Baseline and end-of-treatment data will be required. At routine clinic visits, app-based image capture and symptom entry will also be performed to create clinic-matched assessments; AI-derived outputs will be compared with clinician-assessed TED parameters obtained the same day. At least two clinic-matched assessments per participant will be required for longitudinal evaluation. AI-generated outputs will not be used for real-time clinical decision-making.
- Being tested
- Smartphone-based AI self-monitoring application (Glandy CAS/EXO/LID)
- Keywords
- Thyroid eye disease, TED, Graves orbitopathy, Artificial intelligence, Smartphone, Self-monitoring, Clinical Activity Score, CAS, Exophthalmometry, MRD1, MRD2, Remote monitoring, Digital health, Telemedicine
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based AI self-monitoring application (Glandy CAS/EXO/LID)Device
A smartphone application through which participants complete a symptom questionnaire (diplopia; pain by visual analog scale) and capture a standardized frontal facial photograph at least weekly during the treatment course, and additionally at each routine clinic visit. Submitted images are transmitted to a central analysis system for AI-based processing that generates three analytic outputs:
- Glandy CAS - CAS-related output derived from periocular signs and symptom input
- Glandy EXO - image-based exophthalmometric estimate (surrogate of Hertel)
- Glandy LID - eyelid-related parameters including MRD1/MRD2 equivalents AI outputs are used for research analysis only and are NOT returned to the treating clinician for real-time decision-making during the study.
| Study group | Role | What they receive |
|---|---|---|
| TED - Non-surgical treatment cohort | Adults with TED initiating non-surgical treatment who perform smartphone-based self-monitoring (weekly symptom entry + facial image capture) during the treatment course, with clinic-matched assessments at routine visits. Receives: Device: Smartphone-based AI self-monitoring application (Glandy CAS/EXO/LID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between Glandy CAS and clinician-assessed CAS total score
Agreement between AI-derived Clinical Activity Score (Glandy CAS) and clinician-assessed CAS total score at clinic-matched visits, using intraclass correlation coefficient (ICC), correlation analysis, and Bland-Altman analysis.
Measured: At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
Agreement between Glandy EXO and Hertel exophthalmometry
Agreement between AI-derived image-based exophthalmometric estimate (Glandy EXO, mm) and clinician-measured Hertel exophthalmometry absolute value (mm) at clinic-matched visits, using ICC, correlation, and Bland-Altman analysis.
Measured: At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
Agreement between Glandy LID and clinician-measured MRD1/MRD2
Agreement between AI-derived eyelid parameters (Glandy LID: MRD1 and MRD2 equivalents, mm) and clinician-measured MRD1 and MRD2 (mm) at clinic-matched visits, using ICC, correlation, and Bland-Altman analysis.
Measured: At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
Secondary outcomes (7)
Longitudinal change in AI-derived TED parameters
Descriptive longitudinal change in Glandy CAS, Glandy EXO, and Glandy LID obtained from serial home-monitoring data during the non-surgical treatment course.
Measured: Weekly home monitoring from baseline to end-of-treatment (up to 12 months)
Concordance between AI-derived longitudinal trends and interval clinical change
Concordance between longitudinal AI-derived parameter trends and interval clinical change observed at routine follow-up, analyzed with descriptive paired comparisons and repeated-measures / mixed-effects approaches as appropriate.
Measured: From baseline to end-of-treatment (up to 12 months)
Feasibility: adherence to weekly home-based image capture
Proportion of participants performing at least weekly home-based facial image capture using the study application.
Measured: Throughout treatment period (up to 12 months)
Feasibility: adherence to symptom reporting
Number and proportion of completed in-app symptom reports (diplopia, VAS pain) relative to expected weekly submissions.
Measured: Throughout treatment period (up to 12 months)
Feasibility: completion of clinic-matched assessments
Number and proportion of participants completing ≥2 clinic-matched assessments including baseline and at least one post-baseline assessment.
Measured: Throughout treatment period (up to 12 months)
Relationship between patient-reported symptoms and AI-derived measurements
Association between patient-reported diplopia and VAS pain with AI-derived parameters over time, explored descriptively and with regression / mixed-effects models where appropriate.
Measured: Throughout treatment period (up to 12 months)
Clinical utility of serial AI-based monitoring between clinic visits
Ability of serial AI-derived monitoring to provide clinically useful adjunctive information regarding early improvement or interval worsening between routine clinic visits (descriptive).
Measured: Throughout treatment period (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye Disease (TED)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- THYROSCOPE INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623993
- Sponsor's protocol ID
- THYROSCOPE-TED-2026-01
- Acronym
- THYROSCOPE-TED
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The dataset includes patient-captured smartphone facial photographs, which are inherently identifiable biometric data. Public sharing of individual participant data (IPD) would pose a substantial risk of re-identification that cannot be fully mitigated by standard de-identification of tabular variables alone. The informed consent obtained from participants and the IRB-approved protocol do not authorize broad third-party sharing of these facial images or associated individual-level records. In addition, the study is conducted in the Republic of Korea and is subject to the Personal Information Protection Act (PIPA) and the Bioethics and Safety Act, which restrict external transfer of identifiable health and biometric information. For these reasons, individual-level data will not be shared publicly. Reasonable requests for scientifically justified collaborative analyses may be considered on a case-by-case basis, subject to a data-use agreement, sponsor approval, and applicable ethics appr
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Smartphone-Based Self-Monitoring Using an Artificial Intelligence Solution During Non-Surgical Treatment for Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT07623993
- Acronym / sponsor ID
- THYROSCOPE-TED / THYROSCOPE-TED-2026-01
- Keywords
- Thyroid eye disease, TED, Graves orbitopathy, Artificial intelligence, Smartphone, Self-monitoring, Clinical Activity Score, CAS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- THYROSCOPE INC.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Jun 2026 (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 prospective observational study evaluates the feasibility and clinical utility of a smartphone-based artificial intelligence (AI) self-monitoring system in adults with thyroid eye disease (TED) undergoing non-surgical treatment. Eligible participants will use their own smartphones and the study application (Glandy) to perform at least weekly home monitoring consisting of a symptom questionnaire (diplopia, pain on visual analog scale) and a standardized frontal facial photograph. AI-derived outputs (Glandy CAS, Glandy EXO, Glandy LID) obtained at routine clinic visits will be compared with standard clinician assessments (CAS total score, Hertel exophthalmometry, MRD1/MRD2). AI outputs will not be used for real-time clinical decision-making during the study.
Detailed description
Thyroid eye disease (TED) is an autoimmune inflammatory disorder most commonly associated with Graves' disease. Clinical manifestations include conjunctival injection, eyelid swelling, eyelid retraction, proptosis, diplopia, and altered ocular appearance. TED typically progresses through an active inflammatory phase of approximately 6-12 months before transitioning to a relatively inactive phase, although interval worsening may occur. Because treatment response can change dynamically, timely assessment of disease activity and severity is important for monitoring.
In current practice, TED activity and severity are primarily assessed during in-person visits using the Clinical Activity Score (CAS), Hertel exophthalmometry, and eyelid measurements (MRD1/MRD2). These assessments are episodic and may not capture interval change between visits.
Recent advances in AI have enabled image-based quantification of TED-related features from facial or periocular photographs. The AI-based monitoring system evaluated here has three analytic components: Glandy CAS (CAS-related outputs from photographs + symptom input), Glandy EXO (image-based exophthalmometric estimate), and Glandy LID (eyelid-related parameters including MRD measurements).
This prospective observational study will enroll approximately 200 adults with TED scheduled to initiate non-surgical treatment (intravenous methylprednisolone, oral corticosteroids, radiotherapy, or biologic therapy). Participants will perform at least weekly home-based self-monitoring (symptom entry + standardized frontal facial image) using their own smartphones and the study application. Baseline and end-of-treatment data will be required. At routine clinic visits, app-based image capture and symptom entry will also be performed to create clinic-matched assessments; AI-derived outputs will be compared with clinician-assessed TED parameters obtained the same day. At least two clinic-matched assessments per participant will be required for longitudinal evaluation. AI-generated outputs will not be used for real-time clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TED - Non-surgical treatment cohort | – | Device: Smartphone-based AI self-monitoring application (Glandy CAS/EXO/LID)Adults with TED initiating non-surgical treatment who perform smartphone-based self-monitoring (weekly symptom entry + facial image capture) during the treatment course, with clinic-matched assessments at routine visits. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥19 years) with clinically diagnosed TED who are scheduled to initiate active non-surgical treatment at participating ophthalmology sites.
Key inclusion criteria (7 listed)
- Adults aged 19 years or older with a clinical diagnosis of thyroid eye disease (TED).
- Patients with TED scheduled to initiate active non-surgical treatment, including but not limited to intravenous methylprednisolone, oral corticosteroids, radiotherapy, or biologic therapy.
- Able to undergo baseline clinical assessment prior to initiation of the planned treatment course and expected routine follow-up evaluation during treatment, including an end-of-treatment assessment.
- Able and willing to use their own smartphone to complete the study application-guided symptom questionnaire and capture standardized frontal facial images throughout the study period.
- Willing to perform at least weekly home-based image capture and symptom reporting during the treatment course.
Key exclusion criteria (6 listed)
- Severe eyelid deformities, facial deformities, or other facial/periocular conditions that may interfere with standardized image acquisition or reliable AI-based image analysis.
- Unable to use the study application or smartphone-based image capture procedure adequately for protocol-required self-monitoring.
- Undergoing or planning to undergo surgical treatment for TED as the primary treatment modality during the study period.
- History of ocular, eyelid, or orbital surgery within 3 months prior to enrollment.
- Any medical, psychiatric, cognitive, or other condition that, in the investigator's judgment, may compromise protocol compliance, study participation, or data integrity.
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 |
|---|---|---|
| Smartphone-based AI self-monitoring application (Glandy CAS/EXO/LID)A smartphone application through which participants complete a symptom questionnaire (diplopia; pain by visual analog scale) and capture a standardized frontal facial photograph at least weekly during the treatment course, and additionally at each routine clinic visit. Submitted images are transmitted to a central analysis system for AI-based processing that generates three analytic outputs: * Glandy CAS - CAS-related output derived from periocular signs and symptom input * Glandy EXO - image-based exophthalmometric estimate (surrogate of Hertel) * Glandy LID - eyelid-related parameters including MRD1/MRD2 equivalents AI outputs are used for research analysis only and are NOT returned to the treating clinician for real-time decision-making during the study. | Device | TED - Non-surgical treatment cohort |
Primary outcome
Agreement between Glandy CAS and clinician-assessed CAS total score
Time frame: At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
Agreement between AI-derived Clinical Activity Score (Glandy CAS) and clinician-assessed CAS total score at clinic-matched visits, using intraclass correlation coefficient (ICC), correlation analysis, and Bland-Altman analysis.
Agreement between Glandy EXO and Hertel exophthalmometry
Time frame: At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
Agreement between AI-derived image-based exophthalmometric estimate (Glandy EXO, mm) and clinician-measured Hertel exophthalmometry absolute value (mm) at clinic-matched visits, using ICC, correlation, and Bland-Altman analysis.
Agreement between Glandy LID and clinician-measured MRD1/MRD2
Time frame: At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
Agreement between AI-derived eyelid parameters (Glandy LID: MRD1 and MRD2 equivalents, mm) and clinician-measured MRD1 and MRD2 (mm) at clinic-matched visits, using ICC, correlation, and Bland-Altman analysis.
7 secondary outcomes
Longitudinal change in AI-derived TED parameters
Time frame: Weekly home monitoring from baseline to end-of-treatment (up to 12 months)
Concordance between AI-derived longitudinal trends and interval clinical change
Time frame: From baseline to end-of-treatment (up to 12 months)
Feasibility: adherence to weekly home-based image capture
Time frame: Throughout treatment period (up to 12 months)
Feasibility: adherence to symptom reporting
Time frame: Throughout treatment period (up to 12 months)
Feasibility: completion of clinic-matched assessments
Time frame: Throughout treatment period (up to 12 months)
Relationship between patient-reported symptoms and AI-derived measurements
Time frame: Throughout treatment period (up to 12 months)
Clinical utility of serial AI-based monitoring between clinic visits
Time frame: Throughout treatment period (up to 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. The dataset includes patient-captured smartphone facial photographs, which are inherently identifiable biometric data. Public sharing of individual participant data (IPD) would pose a substantial risk of re-identification that cannot be fully mitigated by standard de-identification of tabular variables alone. The informed consent obtained from participants and the IRB-approved protocol do not authorize broad third-party sharing of these facial images or associated individual-level records. In addition, the study is conducted in the Republic of Korea and is subject to the Personal Information Protection Act (PIPA) and the Bioethics and Safety Act, which restrict external transfer of identifiable health and biometric information. For these reasons, individual-level data will not be shared publicly. Reasonable requests for scientifically justified collaborative analyses may be considered on a case-by-case basis, subject to a data-use agreement, sponsor approval, and applicable ethics appr
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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.
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 (TED) and Graves Ophthalmopathy, run by THYROSCOPE INC. at 1 site in United States.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 3 Jun 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaemin Park (+82 52-264-4154, jaemin.park@thyroscope.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between Glandy CAS and clinician-assessed CAS total score (time frame: At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)). The study lists 3 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 3 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.