Effect of a Novel Thermostatic Device on Meibomian Gland Dysfunction: A Randomized Controlled Trial in Chinese Patients

Abstract BackgroundAs a chronic disease, meibomian gland dysfunction (MGD) which causes excessive evaporation of tears by changing the tear film composition, is considered a leading cause of dry eye. Although a variety of physical therapy equipment, there is currently no economical and effective treatment for MGD. The aim of this study was to evaluate the effectiveness and safety of the MiBoFlo Thermoflo® (Mibo Medical, Dallas, TX, USA), a new thermostatic device, on both objective symptoms and subjective signs in Chinese MGD patients.MethodsThis was a prospective, randomized, controlled clinical trial. 108 eyes of 54 MGD patients in Beijing Tongren Hospital were recruited and randomized 1:1 to MiBoFlo (n = 54 eyes) or LipiFlow® (TearScience, Morrisville, NC, USA) (n = 54 eyes) treatment group. In the MiBoFlo group, treatment for each eye took 10 minutes and proceeded every two weeks for a total of three times. Patients in the LipiFlow group received a single 12-minute treatment. Main Outcome Measures: The primary outcomes include changes in Ocular Surface Disease Index (OSDI) score, Meibomian Glands Yielding Liquid Secretion (MGYLS) score and Meibomian Glands Secretion (MGS) score from baseline to 2 months. The secondary outcomes include Tear Meniscus Height (TMH), Non-invasive Keratograph Break-up Time (NIKBUT), Corneal Fluorescein Staining (CFS) and Meibomian Glands (MG) loss from baseline to 2 months. Safety outcomes include visual acuity (VA), intraocular pressure (IOP), anterior segment and facial skin.ResultsThe OSDI score, MGYLS score and MGS score all improved from baseline to 1 month in both MiBoFlo and LipiFlow group, and these improvements were maintained at 2 months. CFS score, NIKBUT and MG loss had no significant change in both groups. CFS score improvement in MiBoFlo group were significantly more obvious than in LipiFlow group in the follow-up visit (p<0.01).ConclusionAs a portable and comfortable device, MiBoFlo treatment can offer an advancement for the treatment of MGD and a course of treatment results in at least two months of sustained improvement in both symptoms and meibomain gland function.