Evaluation of Low-Level Light Therapy on Meibomian Glands Study

Last updated: December 5, 2023
Sponsor: University of Houston
Overall Status: Completed

Phase

N/A

Condition

Dry Eyes

Dry Eye Disease

Blepharitis

Treatment

Red Low-Level Light Therapy

Clinical Study ID

NCT05859295
STUDY00004024
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to examine the effect of low-level light therapy (LLLT) on meibomian gland dysfunction and dry eye disease. The main questions it aims to answer are:

  1. Does low-level light therapy reduce levels of pro-inflammatory proteins in meibum

  2. Does low-level light therapy increase the ratio of non-polar lipids to polar lipids in meibum

Participants will receive 3 15-minute sessions of low-level light therapy. Meibum will be collected before the first treatment and after the final treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or older at enrollment
  • Individuals with mild to moderate meibomian gland dysfunction based on clinical signs,e.g., meibum quality score of 1-3, meibography score of 1, 2, or 3 on the PultMeiboscale, non-invasive 1st tear break up time of 10 seconds or less, or an OcularSurface Disease Index (OSDI) score of 13 to 32 points

Exclusion

Exclusion Criteria:

  • History of systemic disease associated with aqueous-deficient dry eye disease (e.g.,Sjogren's syndrome)
  • History of corneal surgery, refractive surgery, eyelid surgery or ocular trauma within 6 months
  • History of LipiFlow, iLux, Meiboflow, Intense Pulsed Light (IPL) or low level lighttherapy (LLLT) within the last 12 months
  • Use of photosensitizing medications
  • Pregnant and/or lactating females
  • Pigmented lesions, tattoos, or skin cancer in the periocular region

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Red Low-Level Light Therapy
Phase:
Study Start date:
June 07, 2023
Estimated Completion Date:
November 11, 2023

Study Description

Low-level light therapy (LLLT) is a treatment for meibomian gland dysfunction. The proposed mechanism of action is photobiomodulation of cells leading to improved adenosine triphosphate synthesis, reduction of reactive oxygen species in oxidatively-stressed cells, and the activation of transcription factors involved in cellular proliferation, migration and survival. Understanding of how low-level light therapy based therapy alters meibomian gland function is poor. This study will examine the effect of low-level light therapy on individuals with meibomian gland dysfunction. Eligible subjects will receive 15 minutes of low-level light therapy per week over a 3 week period. Meibum collected prior to treatment will be compared to meibum collected after 3 treatment sessions for alteration in protein and lipid composition.

Connect with a study center

  • The University of Houston College of Optometry

    Houston, Texas 77204
    United States

    Site Not Available

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