Mechanisms of Light-based Therapies for Dry Eye Disease (MOLT)
Dry Eye Syndromes, Meibomian Gland Dysfunction
About this trial
This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Intense pulsed light therapy, Low-level light therapy
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) (Wolffsohn et al., 2017) 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 2 to grade 4 of either eyelid [Pult and Reide-Pult, 2013]) will also justify a diagnosis of Meibomian gland dysfunction Age ≥ 18 years, male or female Able to provide written consent in English Able to attend multiple visits (4 treatment visits) and followed up for 2 weeks and 3 months after final treatment Exclusion Criteria: Pregnancy Contraindications to IPL treatment (Individuals with darker skin types - Fitzpatrick skin type V or VI, photosensitive epilepsy, tattoos, implants, electrical or acoustic prosthetics, semi-permanent make-up, pigmented lesions or skin cancer in the treatment area, pacemakers, use of photosensitising medication the past 3 months or during treatment period) Facial or ocular IPL or LLLT treatment within the past 6 months or during study period in addition to those provided in the study Use of topical medical eyedrops in the past 3 months or during study period Contact lens wear in the past 2 weeks or during study period Systemic conditions that can cause dry eye disease or corneal nerve loss including diabetes and Sjögren's syndrome Other active ocular surface diseases or history of ocular surgery or corneal infections Individuals with 1 eye
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Actual IPL and LLLT
Sham IPL and LLLT
IPL and LLLT will be administered using the Espansione Group Ltd Eye-light unit. Five pulses of IPL will be administered along the lower lid region of the eye after the Pult meiboscore and Fitzpatrick skin grading has been entered into the unit. LLLT consisting of a wearable facial mask with red LEDs is then administered for 15 minutes.
Sham IPL will be administered by placing a separate empty IPL cartridge on the lower eyelid regions of the patient's other eye while a working IPL cartridge (Espansione Group Ltd Eye-light unit) simulates a light pulse pointed away from the patient's face, after entering the Pult meiboscore and Fitzpatrick skin grading into the unit. Five simulated pulses will be administered. LLLT consisting of a wearable facial mask with red LEDs is then administered for 15 minutes.