Dry Eye, Meibomian Gland Dysfunction (Disorder)
Conditions
Keywords
Dry Eye, Meibomian Gland, LLLT, Low-level light therapy
Brief summary
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.
Detailed description
The primary objective of the study is to determine if there is a difference in the thermal effect of low-level light therapy (LLLT) in individuals with different skin pigmentation (Fitzpatrick skin type I-IV verses Fitzpatrick skin type V-VI) using a clinically available 633nm LLLT system, the Epi-C-Plus (Espansione group, Bologna, Italy).
Interventions
DEVICEThree 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.
Sponsors
University of Houston
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eyelid temperature | Eyelid temperature will be measured before and after 15 minutes of low-level light therapy at the baseline visit. |
Secondary
| Measure | Time frame |
|---|---|
| Ocular Surface Disease Index Questionnaire | After 3 low-level light therapy treatment sessions through study completion, an average of 1 week. |
| Tear break up time | After 3 low-level light therapy treatment sessions through study completion, an average of 1 week. |
Countries
United States
Contacts
Primary ContactEric Ritchey, OD, PhD
Backup ContactRachel Redfern, OD, PhD
Outcome results
None listed