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Treating Meibomian Gland Disease in a Pediatric Population

NCT07229001 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-11-14

No results posted yet for this study

Summary

Dry Eye Disease (DED) is commonly encountered among eye care professionals. DED is a disease of the tears and ocular surface that is multi-factorial resulting in a wide range of symptoms and signs with potentially damaging effects. As technology continues to evolve and as digital devices become more available in social, work environments, and in school settings, patients are increasingly complaining of ocular discomfort and fluctuations in their vision.

In order to diagnose DED which encompasses Meibomian gland dysfunction (MGD), a detailed case history of \\patients' symptoms along with imaging to investigate the amount of disease present in their eyes is needed. A customized questionnaire and the Keratograph meibographer will allow for a subjective and objective investigation of dry eye disease in patients. Artificial tears and warm compress are traditional methods used to treat DED. However, many patients continue to have progression of disease. The Marco Equinox Low Level Light Therapy (LLLT) utilizes a LED mask to apply red light to the periorbital and cheekbone regions of the face, which effectively normalizes meibomian gland function. This is a non-invasive treatment of both the upper and lower eyelids, which does not require a gel application. Treatment of both eyes takes approximately 15 minutes. In the clinical studies that have been published, lipid layer interference pattern, non-invasive tear break up time, lissamine green conjunctival staining, Schirmer's test, and upper meibography scores showed significant improvement by 4 weeks after the start of treatment with LLLT. To our knowledge, this has not been studied in the pediatric population, but the disease process is the same. Thus, the study purpose is to determine the treatment effect of LLLT on MGD and DED comparing to traditional treatment (warm compress and artificial tear) only in children.

Conditions

  • Dry Eye Disease, Meibomian Gland Disease

Interventions

OTHER

Low level light treatment

, LLLT has been confirmed to produced significant improvements in meibomian gland function and symptoms. However, it has not been tested in children. Thus, the study purpose is to determine the treatment effect of LLLT on MGD and DED comparing to using warm compress and artificial tear only in children.

OTHER

warm compress and artificial tear

Artificial tears and warm compress have been the traditional treatments for DED.

Sponsors & Collaborators

  • Illinois College of Optometry

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • United States

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 NCT07229001 on ClinicalTrials.gov