Evaluation of Low-Level Light Therapy on Meibomian Glands Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Houston
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Meibum protein composition
Study Overview
Brief 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:
- Does low-level light therapy reduce levels of pro-inflammatory proteins in meibum
- 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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Meibum protein composition
Time Frame: 3 weeks
Proteomic analysis of meibum collected before and after low level light therapy
Secondary Outcomes
- Meibum lipid composition(3 weeks)
Investigators
Eric R. Ritchey
Assistant Professor
University of Houston