Effect of Low-Level Light Therapy on Ocular Surface Parameters in Patients With Graves Disease
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- Who runs it
- Grigore T. Popa University of Medicine and Pharmacy
- Trial code
- NCT07332988
- Record updated
- 12 January 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Diagnosed with dry eye disease, particularly associated with Graves' ophthalmopathy; Refractory to conventional dry eye treatments (e.g., artificial tears, cyclosporine, corticosteroid eye drops); Adult patients (over 18 years old).
Exclusion: Use of general corticosteroids in the last 6 months; Ocular or orbital surgery in the last 6 months; Uncontrolled systemic diseases (other than Graves' disease); Active ocular infection or allergy; Pregnant or breastfeeding; Use of contact lenses within the last week.