Status:

RECRUITING

Low Level Light Therapy & Skin Pigmentation

Lead Sponsor:

University of Houston

Conditions:

Dry Eye

Meibomian Gland Dysfunction (Disorder)

Eligibility:

All Genders

18+ years

Phase:

NA

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 e...

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 ty...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 11 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2026

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT07173530

Start Date

June 11 2025

End Date

August 1 2026

Last Update

September 15 2025

Active Locations (1)

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1

The University of Houston College of Optometry

Houston, Texas, United States, 77204