Low Level Light Therapy & Skin Pigmentation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus)..
- Who it may be relevant to
- Registry conditions: Dry Eye, Meibomian Gland Dysfunction (Disorder). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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.
Primary outcome measures
- Eyelid temperature [Time frame: Eyelid temperature will be measured before and after 15 minutes of low-level light therapy at the baseline visit.]
Secondary outcome measures (2)
- Ocular Surface Disease Index Questionnaire [Time frame: After 3 low-level light therapy treatment sessions through study completion, an average of 1 week.]
- Tear break up time [Time frame: After 3 low-level light therapy treatment sessions through study completion, an average of 1 week.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Houston College of Optometry — Houston
Identifiers
NCT: NCT07173530 · STUDY00005386/MOD00007330