Low Level Light Therapy & Skin Pigmentation

University of Houston

Status: Enrolling

Conditions: Dry Eye; Meibomian Gland Dysfunction (Disorder)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07173530

STUDY00005386/MOD00007330

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Fitzpatrick skin tone I-IV

Experimental group

Description:

Individuals with skin tones I-IV on the Fitzpatrick scale will receive low-level light therapy

Treatment:

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

Fitzpatrick skin tone V-VI

Experimental group

Description:

Individuals with skin tones V-Vi on the Fitzpatrick scale will receive low-level light therapy

Treatment:

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