RECRUITINGINTERVENTIONAL
Low Level Light Therapy & Skin Pigmentation
About This Trial
The goal of this clinical trial is to determine if there is a difference in eyelid temperature after low-level light therapy (LLLT) in individuals with different amounts of skin pigmentation and dry eye/meibomian gland disease. Participants will have 3 fifteen minute in office LLLT therapy sessions over a period of approximately 7 to 14 days.
Who May Be Eligible (Plain English)
Who May Qualify:
- Ability to read and understand the study willing to sign a consent form in English
- Age 18 years or older at enrollment
- Individuals with MGD based on one or more of the following clinical signs/symptoms, e.g., meibum quality score of 1-3 (Bron et al.), 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 greater than 12 points.
Who Should NOT Join This Trial:
- Active anterior segment pathology (e.g., bacterial conjunctivitis, microbial keratitis)
- History of systemic disease associated with aqueous-deficient dry eye disease (e.g., Sjogren's syndrome)
- History of corneal surgery, refractive surgery, or eyelid surgery within 6 months
- History of corneal ectasia (e.g. keratoconus, Pellucid marginal degeneration)
- History of ocular trauma within 6 months
- History of LipiFlow, iLux, Meiboflow, IPL or LLLT within the last 12 months
- Habitual use of photosensitizing medications within the last 30 days
- Pregnant and/or lactating females, by self-report
- Pigmented lesions, tattoos, or skin cancer in the periocular region
- Unwilling to have eyes photographed or video recorded
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Ability to read and understand the study informed consent in English
* Age 18 years or older at enrollment
* Individuals with MGD based on one or more of the following clinical signs/symptoms, e.g., meibum quality score of 1-3 (Bron et al.), 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 greater than 12 points.
Exclusion Criteria:
* Active anterior segment pathology (e.g., bacterial conjunctivitis, microbial keratitis)
* History of systemic disease associated with aqueous-deficient dry eye disease (e.g., Sjogren's syndrome)
* History of corneal surgery, refractive surgery, or eyelid surgery within 6 months
* History of corneal ectasia (e.g. keratoconus, Pellucid marginal degeneration)
* History of ocular trauma within 6 months
* History of LipiFlow, iLux, Meiboflow, IPL or LLLT within the last 12 months
* Habitual use of photosensitizing medications within the last 30 days
* Pregnant and/or lactating females, by self-report
* Pigmented lesions, tattoos, or skin cancer in the periocular region
* Unwilling to have eyes photographed or video recorded
Treatments Being Tested
DEVICE
Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus).
A mask with Light Emitting Diodes wavelength 633nm will be placed over closed eyes for 15 minutes.
Locations (1)
The University of Houston College of Optometry
Houston, Texas, United States