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Evaluation of Low-Level Light Therapy on Meibomian Glands Study

NCT ID: NCT05859295

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-07

Study Completion Date

2023-11-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Meibomian Gland Dysfunction Dry Eye

Keywords

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Meibomian glands meibomian gland dysfunction tears

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Low-Level Light Therapy

All subjects will receive 3 15-minute treatments of low level light therapy

Group Type OTHER

Red Low-Level Light Therapy

Intervention Type DEVICE

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

Interventions

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Red Low-Level Light Therapy

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

Intervention Type DEVICE

Other Intervention Names

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Marco Equinox

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role collaborator

University of Houston

OTHER

Sponsor Role lead

Responsible Party

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Eric R. Ritchey

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric R Ritchey, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Houston College of Optometry

Locations

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The University of Houston College of Optometry

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00004024

Identifier Type: -

Identifier Source: org_study_id