A Randomized, Controlled Treatment Trial of Eyelid-Warming Therapies in Meibomian Gland Dysfunction

Abstract

Aim The main treatment for meibomian gland dysfunction (MGD), a major cause of dry eye, is eyelid warming. Lack of compliance is the main reason for treatment failure. This has led to the development of eyelid-warming devices that are safe, effective and convenient. To obtain robust evidence demonstrating their efficacy, the authors conducted a 3-arm randomized clinical study.MethodsThe authors conducted a 3-month assessor-blinded, randomized, controlled trial of patients from the Singapore National Eye Centre experiencing at least one of eight dry eye symptoms ‘often’ or ‘all the time’. Patients who wore contact lenses, had an active infection or known diagnosis of thyroid dysfunction and rheumatoid arthritis were excluded from the study. MGD participants were randomly assigned to warm towel (n = 25), EyeGiene® (Eyedetec Medical Inc., Danville, CA, USA) (n = 25) and Blephasteam® (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK) (n = 25) treatments. The primary efficacy and safety outcomes included the proportions of participants with improved symptoms and changes in best corrected visual acuity (BCVA), respectively. Other outcomes included tear break up time (TBUT), Schirmer test, corneal fluorescein dye staining and number of visibly occluded meibomian gland (MG) orifices.ResultsThe study population was 53.5 ± 11.1 years old and predominantly Chinese. For severity of symptom after 3 months of treatment, 78.3% Blephasteam® participants reported improvement compared to 45.5% warm towel participants (p = 0.023). The corresponding proportions for improvement in the frequency of symptoms were 82.6% and 50.0%, respectively (p = 0.020). The proportions of improvement of symptoms in EyeGiene® patients were not significantly different from warm towel intervention. At 1 month of treatment, the crude odds ratio of improvement of severity of irritation for Blephasteam® compared to control was 3.0 (95% CI 0.88–10.18). However, the odds ratio adjusted by age was 5.67 (1.30–24.66). The lid-warming treatments did not significantly change the TBUT, Schirmer test results or number of visibly occluded MGs in the study period. All treatment modalities did not worsen BCVA after 3 months.ConclusionBlephasteam® is more effective than warm towel for MGD treatment, with warm towel and EyeGiene® being comparable effective. Older age might predict for treatment efficacy. All studied therapies were safe for visual acuity (VA) for 3 months of treatment.Electronic supplementary materialThe online version of this article (doi:10.1007/s40123-014-0025-8) contains supplementary material, which is available to authorized users.

Longitudinal Changes in Tear Evaporation Rates After Eyelid Warming Therapies in Meibomian Gland Dysfunction

“…Irritative symptoms in MGD patients were previously found to improve after lid warming. 9 The current findings suggest that these symptomatic improvements in this original publication were not due to purely subjective effects but could be related to reduced rates of TE. Previously, the association of changes in levels of specific tear lipids with TE rates was also reported, 23 and these lipids may have functional roles in stabilizing the tear.…”

“…9,10 The SingHealth Centralized Institutional Review Board has approved this study, and the Tenets of the Declaration of Helsinki were followed. From February 2012 to March 2013, all patients who met the eligibility criteria at the dry eye clinic in Singapore National Eye Center went through study briefing and were invited for screening.…”

“…The following inclusion criteria for this study have been published, 9 and for easy reference are specified here: at least one of eight dry eye symptoms experienced often or all the time; at least one meibomian gland opening with pouting and a visible plug above the eyelid margin that cannot be removed by gentle wiping with a cotton tip; and no ocular pathology requiring treatment within the last month and during the study. 9 …”

“…The clinical efficacy has been published separately. 9 The clinical efficacy of Lipiflow, a form of thermopulsation treatment compared with warm towel, was also examined. 10 However, none of these reports have included the effect of lid warming on TE rates.…”

Ex vivo heat retention of different eyelid warming masks

“…In addition to eyelid masks, promising new eyelid warming technologies include steam [17,19,34,35], thermal [36][37][38][39] and chemically activated disposable sachets [40]. Aside from the effect on the meibum, warm compresses can also transiently degrade vision from the light pressure of the compress [41].…”