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Completed

NCT Number: NCT05859295

Evaluation of Low-Level Light Therapy on Meibomian Glands Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Houston College of Optometry

Houston, Texas, 77204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Pult Meiboscale, non-invasive 1st tear break up time of 10 seconds or less, or an Ocular Surface Disease Index (OSDI) score of 13 to 32 points

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 light therapy (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

Treatment and study plan

Red Low-Level Light Therapy

Device

Visible red light (633nm) projected onto the face using an light emitting diode (LED) mask

Other names: Marco Equinox

Primary outcomes

  1. Meibum protein composition

    Time frame: 3 weeks

    Proteomic analysis of meibum collected before and after low level light therapy

Secondary outcomes

  1. Meibum lipid composition

    Time frame: 3 weeks

    Lipidomic analysis of meibum collected before and after low level light therapy

Other outcomes

  1. Non-invasive tear break up time

    Time frame: 3 weeks

    Videokeratoscope assessment of time to break up of the tear film

  2. Tear lipid layer thickness

    Time frame: 3 weeks

    Interferometric assessment of the tear film lipid layer

  3. Tear meniscus height

    Time frame: 3 weeks

    Videokeratoscope assessment of the tear meniscus

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

  • University of Louisville

Registry information

Acronym: ELOM

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 15, 2023
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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