Photobiomodulation with REd Vs BluE Light (REBEL)

Launched by ASTON UNIVERSITY · Apr 15, 2024

Keywords

ClinConnect Summary

The REBEL trial is exploring the effects of two types of low-level light therapy (LLLT) – red light and blue light – on patients suffering from dry eye syndromes, meibomian gland dysfunction (which affects oil production in the eyelids), and blepharitis (inflammation of the eyelids). Researchers want to see how these different light wavelengths impact symptoms like discomfort, tear stability, and the health of the eyelids and eye surface. Participants will receive three treatment sessions over three weeks and will be monitored for a month afterward. This study aims to understand if blue light can help by reducing bacteria, while red light may help by increasing energy and warmth in the affected areas.

To be eligible for this trial, participants must be at least 18 years old and have symptoms of dry eye disease, signs of meibomian gland dysfunction, and a specific eyelid condition called ocular demodicosis. They should also be able to commit to attending four visits in total: three for treatment and one for follow-up. It’s important to note that individuals who are pregnant, have had recent light-based eye treatments, or have certain other eye conditions will not be eligible. This trial could provide helpful insights into new treatment options for managing chronic eye conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Individuals with dry eye disease symptoms (Ocular Surface Disease Index questionnaire (OSDI) score ≥ 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 ≥ 2mm in length and ≥ 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 ≥ 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