Randomized clinical trial: MGrx versus standard debridement and expression for meibomian gland dysfunction.

Abstract

Significance: Evaporative dry eye disease, due to meibomian gland dysfunction, causes significant suffering for millions of people globally, yet satisfactory long-term treatment remains elusive for many. Investigation of potential therapies for meibomian gland dysfunction is therefore of high importance to clinicians and their patients.

Purpose: This study aimed to compare the efficacy of a new device for meibomian gland debridement and expression to that of the conventional way of providing this treatment.

Methods: Thirty participants (mean age, 36.4 ± 15.4 years; 77% female) fulfilling current Tear Film & Ocular Surface Society diagnostic criteria for dry eye disease and meibomian gland dysfunction were recruited (Research Registry, 10340). Fifteen participants each were randomized to receive a single treatment with either traditional debridement (using a golf-club spud), heating (10 minutes of Blepha EyeBag, Théa Laboratories, Clermont-Ferrand, France) and expression (with forceps), or the multimodal MGrx, which comprises a handheld device with heated debridement, massage, and expression attachments. Symptomatology, tear film, and ocular surface measures were assessed at baseline and at 4 and 8 weeks post-treatment.

Results: Ocular Surface Disease Index, 5-Item Dry Eye Questionnaire, and Symptom Assessment in Dry Eye symptom questionnaire scores all improved significantly with both treatments (all p<0.001), with no subsequent deterioration for at least 8 weeks. The improvement was similar between treatment groups (all p>0.05). Clinical signs, of blink rate, tear film quality and quantity, ocular surface characteristics, and meibomian gland expressibility, were all unchanged with both treatments (all p>0.05) except for noninvasive tear breakup time, which deteriorated in the conventional treatment group (p=0.006) between 4 and 8 weeks post-treatment. No adverse reactions were reported, and all participants were able to tolerate treatment.

Conclusions: A single application of meibomian gland debridement and expression resulted in sustained improvements in the symptoms of dry eye disease, in both treatment groups. The MGrx device provides a safe and effective in-office treatment for evaporative dry eye disease, and has time and space advantages compared with conventional treatment.