None listed
Conditions
Brief summary
Dry eye is a widespread disease that can affect individuals of any age. People who suffer from this condition frequently complain of irritated, burning and gritty eyes. A common reason for this is a reduction of the tear film lipid layer due to the eyelid glands malfunctioning (meibomian gland dysfunction). Intense pulsed light (IPL) therapy conventionally used to treat facial pigmentation has been found serendipitously to provide dry eye relief in meibomian gland dysfunction (MGD). A prospective trial of IPL for the treatment of MGD by the lead investigator’s team confirmed significant improvements. On account of our previous research in this area, we are conducting an evaluation on the effectiveness of IPL for the relief of evaporative dry eye. The study aims to provide more information about the management of MGD, so that optometrists and ophthalmologists can improve clinical decisions in practice. We are recruiting up to 100 participants with symptoms of dry eye; the study will be carried out by New Zealand registered optometrists in the Department of Ophthalmology at the University of Auckland. Participants will attend at least five visits, over a period of 105 days (15 weeks). Three of the visits will each take up to 45 minutes, and the remaining two will each take approximately 80-90 minutes. The E-Eye IPL device used in this study will be applied to the skin area below the eyes; it is a commercially available and medically certified product, applied according to manufacturer's instructions. The procedures performed are all standard clinical tests.
Interventions
Brief name: Treatment of meibomian gland dysfunction (MGD) with intense pulsed light (IPL)
Description: Eligible participants with various severities of symptomatic MGD will be recruited for the interventional study, and provided with a Participant Information Sheet. Volunteers have the opportunity to discuss any concerns with the researchers prior to signing a written consent form. Eligible participants will be required to attend at least five visits over 105 days. All products involved in the
Brief name: Treatment of meibomian gland dysfunction (MGD) with intense pulsed light (IPL) Description: Eligible participants with various severities of symptomatic MGD will be recruited for the interventional study, and provided with a Participant Information Sheet. Volunteers have the opportunity to discuss any concerns with the researchers prior to signing a written consent form. Eligible participants will be required to attend at least five visits over 105 days. All products involved in the study are commercially available, and all tests performed are standard clinical procedures and will be carried out by New Zealand registered therapeutic optometrists. Research procedures will be performed at the Ocular Surface Laboratory, Department of Ophthalmology, University of Auckland, New Zealand. In this prospective, double-masked, placebo-controlled trial, four or five adjacent, but overlapping IPL pulses (E-Eye IPL device, E-Swin, France) will be administered to the skin area immediately below the lower eyelid at an intensity level related to the individual’s Fitzpatrick Skin Type (ranging from 9 - 13 J/cm2). IPL therapy will be administered on Day 1, Day 15, Day 45 and Day 75 as per manufacturer’s recommendations. The treatment duration is approximately 20 seconds per eye and this is followed by 40 minutes of standard clinical ophthalmic testing. A fifth ‘follow-up’ visit is arranged on Day 105 to measure clinical outcomes only (no IPL treatment at this visit). Visits on Day 15, 45 and 75 will each take up to 45 minutes; the remaining two visits will each take approximately 80-90 minutes. The IPL therapy will be applied to both eyes of each participant, however, half the participants will be randomly assigned to receive a ‘mock’ treatment. Neither the researcher collecting clinical data, nor the participant will be privy to the treatment group assignment.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants with symptomatic dry eye caused by meibomian gland dysfunction.
Exclusion criteria
Contraindications to light therapy e.g. clinical skin treatments within last two months, implants beneath the lower eyelid area, tattoos, semi-permanent make-up, or pigmented lesions in the treatment area will also be excluded from the study. Contact lens wearers must refrain from wearing contacts within one week of commencing the study, and during the study. Individuals taking prescribed photosensitising medications such as doxycycline within 3 months of study commencement.
Outcome results
None listed