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Photobiomodulation With REd vs BluE Light (REBEL)

RecruitingNAAges 18 Years - anyAllAston University
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In plain words

What the trial is, and whether it could suit you

The use of photobiomodulation or low-level light therapy (LLLT) in the ophthalmic field stemmed from dermatology which has shown impact on skin blood flow and regeneration. There has been a rise in clinical interest with emerging evidence in the benefits of photobiomodulation in managing chronic inflammatory conditions such as dry eye disease including improvements in ocular discomfort symptoms, tear film stability and tear volume. Despite the observed clinical benefits, limited research has been done to compare photobiomodulation utilising different wavelengths, as most research on dry eye disease has focused on red wavelengths. It has been purported that blue wavelengths may disrupt microbial growth while red wavelengths stimulate energy production and hence increase heat in the affected tissues, although research into these differential impacts at the ocular surface and external eye h

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Individuals with dry eye disease symptoms (Ocular Surface Disease Index questionnaire (OSDI) score โ‰ฅ 13 or Dry Eye Questionnaire (DEQ5) score \> 6) and signs (tear film instability measured with non-invasive tear break-up time \< 10 s or ocular surface damage measured using special dyes placed on the front surface of the eyes that temporarily stains any aggravated or damaged cells: \> 5 corneal spots, \> 9 conjunctival spots or lid margin staining โ‰ฅ 2mm in length and โ‰ฅ 25% in width) * Individuals need to also have Meibomian gland dysfunction. The diagnosis of Meibomian gland dysfunction depends on how many of 5 glands in the central lower eyelid can express oil, and the quality of the oil. A diagnosis is made if there is decreased expressibility (grade 1-3 on the Pflugfelder scale) and reduced quality of oil (grade 1-3 on Bron scale). Any presence of gland blockage and/or loss of oil glands grade 1 to grade 4 of either eyelid \[Pult and Reide-Pult, 2013\]) will also justify a diagnosis of Meibomian gland dysfunction. * Individuals will also need to have ocular demodicosis, diagnosed by clinical observation on slit lamp biomicroscope based on signs including collarettes around the base of lashes, visible Demodex tails, or excessive pouting of lash follicles in those with good lid hygiene where Demodex was confirmed by secondary means such as visible Demodex tails. * Age โ‰ฅ 18 years, male or female * Able to provide written consent in English * Able to attend a total of 4 visits: 3 treatment visits and followed up for 1 month after final treatment Exclusion Criteria: * Pregnancy * Ocular light-based therapies including intense pulsed light (IPL) or LLLT treatment within the past 1 month or during study period in addition to those provided in the study * Contact lens wear in the past 2 weeks or during study period * Other active ocular surface diseases or history of ocular surgery or corneal infections the past 6 months
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What it tests

  • Red LLLT
  • Blue LLLT
  • Sham Red LLLT
  • Sham Blue LLLT
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Where

2 sites
University of Auckland
Auckland, New Zealand
Aston Dry Eye Clinic
Birmingham, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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