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

Part of paid clinical trials in San Jose, California.

Sponsor
THYROSCOPE INC.
Study ID
NCT07623993
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Graves Ophthalmopathy
  • Thyroid Associated Ophthalmopathies
  • Thyroid Eye Disease (TED)

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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 Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIP
3003 North First Street #221San JoseCalifornia95134

Find similar trials in San Jose, CA

By research site
3003 North First Street #221· San Jose, CA

Related Studies