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

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Dry Eye Disease (DED), Graves Ophthalmopathy

In brief

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.

Key facts

Study ID

NCT07332988

Run by

Grigore T. Popa University of Medicine and Pharmacy

People needed

30

Starts

2025-08-01

Expected to finish

2026-08-01

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Pregnant or breastfeeding.
• Uncontrolled systemic diseases (other than Graves' disease).
• Use of general corticosteroids in the last 6 months.
• Ocular or orbital surgery in the last 6 months.
• Use of contact lenses within the last week.
• Active ocular infection or allergy.

Where it is running

• University of Medicine and Pharmacy "Grigore T. Popa" — Iași, Iaşi, Romania

Full record on ClinicalTrials.gov

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