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Effect of Low-Level Light Therapy on Ocular Surface Parameters in Patients With Graves Disease

Study acronym: LLLT-Graves
StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 12, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
This prospective, interventional, randomized, controlled, double-blind clinical study evaluates the effect of Low-Level Light Therapy (LLLT) delivered by a polychromatic periocular mask (Eye-light®️) versus a sham device in adults with dry eye disease (DED) associated with Graves' ophthalmopathy, refractory to conventional topical treatment. The LLLT protocol applies photobiomodulation to eyelid and periocular tissues to support meibomian gland function and reduce tear inflammatory biomarkers. The primary endpoint is the change in tear film stability measured by Non-Invasive Tear Break-Up Time (NIBUT) and Fluorescein Tear Break-Up Time (FBUT). Secondary outcomes include symptom scores (OSDI), Schirmer I test, tear osmolarity, ocular surface staining scales, automated conjunctival hyperemia, blink analysis, meibomian gland morphology (meibography/meiboscale), tear inflammatory biomarkers, and safety/tolerability.
Trial Details
NCT Number NCT07332988
Lead Sponsor Grigore T. Popa University of Medicine and Pharmacy
Conditions
(from sponsor)		 Dry Eye Disease (DED), Graves Ophthalmopathy
Related terms Dry Eye Syndromes, Graves Ophthalmopathy
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov