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NCT07173530NARecruiting

Low Level Light Therapy & Skin Pigmentation

University of Houston

Start Date

6/11/2025

Completion Date

8/1/2026

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus).

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Conditions

Dry EyeMeibomian Gland Dysfunction (Disorder)

Locations

The University of Houston College of Optometry

Houston, Texas 77204

United States