Health TrialsbyHealthPanel

Low Level Light Therapy & Skin Pigmentation

ConditionsDry EyeMeibomian Gland Dysfunction (Disorder)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

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

    Device

    A mask with Light Emitting Diodes wavelength 633nm will be placed over closed eyes for 15 minutes.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Fitzpatrick skin tone I-IVExperimental treatment 1 intervention
Group B: Fitzpatrick skin tone V-VIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Eyelid temperature

Time frame
Eyelid temperature will be measured before and after 15 minutes of low-level light therapy at the baseline visit.

Secondary outcomes

1

Ocular Surface Disease Index Questionnaire

Time frame
After 3 low-level light therapy treatment sessions through study completion, an average of 1 week.
2

Tear break up time

Time frame
After 3 low-level light therapy treatment sessions through study completion, an average of 1 week.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Houston

Lead sponsor

Source ClinicalTrials.gov
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