Dry Eye, Meibomian Gland Dysfunction
Conditions
Keywords
Meibomian glands, meibomian gland dysfunction, tears
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: 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
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.
Interventions
DEVICERed Low-Level Light Therapy
Visible red light (633nm) projected onto the face using an light emitting diode (LED) mask
Sponsors
University of Louisville
University of Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Meibum protein composition | 3 weeks | Proteomic analysis of meibum collected before and after low level light therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Meibum lipid composition | 3 weeks | Lipidomic analysis of meibum collected before and after low level light therapy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Non-invasive tear break up time | 3 weeks | Videokeratoscope assessment of time to break up of the tear film |
| Tear lipid layer thickness | 3 weeks | Interferometric assessment of the tear film lipid layer |
| Tear meniscus height | 3 weeks | Videokeratoscope assessment of the tear meniscus |
Countries
United States
Outcome results
None listed