Prospective Observational Study of Smartphone-Based AI Self-Monitoring During Non-Surgical Treatment for Thyroid Eye Disease (THYROSCOPE)

Starting soon

Conditions studied: Thyroid Eye Disease (TED), Graves Ophthalmopathy, Thyroid Associated Ophthalmopathies

In brief

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.

Key facts

Study ID

NCT07623993

Run by

THYROSCOPE INC.

People needed

200

Starts

2026-07-01

Expected to finish

2027-12-31

Last updated by the study team

2026-06-03

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You 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 may not qualify 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.

Where it is running

• 3003 North First Street #221 — San Jose, California, United States

Full record on ClinicalTrials.gov

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