What this study is
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.
What's being tested
- Smartphone-based AI self-monitoring application (Glandy CAS/EXO/LID)
Intervention · 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 details
- Official title
- Prospective Observational Study of Smartphone-Based Self-Monitoring Using an Artificial Intelligence Solution During Non-Surgical Treatment for Thyroid Eye Disease
- Sponsor
- THYROSCOPE INC.
- Conditions
- Thyroid Eye Disease (TED) · Graves Ophthalmopathy · Thyroid Associated Ophthalmopathies
- Enrolling
- 200 people
- Starts
- 2026-07-01
- Est. completion
- 2027-12-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 22 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 open3003 North First Street #221
San Jose, California, United States
- Jaemin Park CEO · Contact+82-52-264-4154jaemin.park@thyroscope.com
Study team
Sponsor
THYROSCOPE INC.
Study ID THYROSCOPE-TED-2026-01
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.