MedTrace Logo

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

NCT07332988 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-12

No results posted yet for this study

Summary

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.

Conditions

  • Dry Eye Disease (DED)
  • Graves Ophthalmopathy

Interventions

DEVICE

Sham (No Treatment)

The sham group had undergone a similar procedure using the Eye-light® device (Espansione Group, Italy), as the one described above but in this case the device emits only 30% of the treatment power. Patients had a similar visual and sensory experience of the treatment but without actual biologic effects. Each treatment session lasted a total of 15 minutes. It is non-pharmacological, non-contact, and well-tolerated. The light is delivered through closed eyelids, ensuring safety and comfort. This approach allowed for masking of participants and investigators to minimise bias, while ensuring that patients in the control group received no active therapeutic exposure.

DEVICE

Low Light Level therapy

The intervention consists of non-invasive periocular photobiomodulation using the Eye-light® device (Espansione Group, Italy), which delivers low-level polychromatic red and near-infrared light through a specially designed mask. The LLLT mask consisted of light emitting diodes (LEDs) with red light, 633 nm wavelengths. The treatment is designed to improve tear film stability, stimulate meibomian gland activity, reduce ocular surface inflammation. This protocol targets cellular mitochondrial activity to enhance tissue repair and anti-inflammatory effects. Each treatment session lasted a total of 15 minutes. It is non-pharmacological, non-contact, and well-tolerated. The light is delivered through closed eyelids, ensuring safety and comfort, and the device used is CE-marked for ophthalmic applications.

Sponsors & Collaborators

  • Grigore T. Popa University of Medicine and Pharmacy

    lead OTHER

Principal Investigators

  • Mihaela Madalina Timofte Zorila · University of Medicine "Gr. T. Popa", Iasi, Romania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Romania

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07332988 on ClinicalTrials.gov