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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorTHYROSCOPE INC.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Smartphone-based AI self-monitoring application (Glandy CAS/EXO/LID)

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators