Comparison of MGD Treatment Device vs. Mechanical Meibomian Gland Expression for the Treatment of Moderate and Severe MGD

My name is Dr. María Ximena Nuñez. I am a cornea, cataract, and refractive surgeon and Director of the Anterior Segment and Refractive Surgery Unit, Vision Sana Research Group, Clinica de Oftalmologia de Cali. I am also Professor on the Faculty of Medicine at Pontificia Universidad Javeriana in Cali, Colombia. My colleagues and I recently reported the results of an investigator-initiated trial that we designed to understand the relative efficacy of eyelid treatment with the Systane iLux® MGD Thermal Pulsation System versus a regimen of mechanical meibomian gland expression in patients with moderate-to-severe MGD. Most dry eye patients have signs of MGD, or meibomian gland dysfunction. On top of this, we know that MGD is chronic and progressive, so it is extremely important to identify clinical approaches that can effectively target this underlying condition. Our prospective, randomized, open-label, controlled study compared the results after one treatment session with Systane iLux® versus five sessions of mechanical meibomian gland expression. We enrolled 131 adult subjects with signs and symptoms of dry eye. These included a score of 13 or greater on the validated OSDI questionnaire and non-invasive tear breakup time of less than 10 seconds. In addition, clinical evidence of MGD in both eyes, based on a meibomian gland score of 15 or less, was required for enrollment. Subjects were randomized 1:1 to the defined treatment groups. In the Systane iLux® group, subjects were treated once, during the baseline visit. In the mechanical expression group, subjects were treated in-office at baseline, and then 1, 3, 6, and 9 months after the initial visit. Changes from baseline OSDI score, non-invasive tear breakup time, and meibomian gland score were evaluated at the 1-, 3-, 6-, 9-, and 12-month follow-up visits. The study also monitored for adverse events. At baseline, the Systane iLux® and mechanical expression groups were similar with respect to mean non-invasive tear breakup time and meibomian gland score, with a significant difference in mean OSDI score. In both treatment groups, all three efficacy measures showed improvement from baseline beginning at 1-month follow-up and sustained through 12 months. Comparing treatment regimens, Systane iLux® was associated with significantly better mean OSDI score, non-invasive tear breakup time, and meibomian gland score than mechanical expression at all follow-up evaluations. These findings were reinforced by multivariate analysis, which showed a greater increase in non-invasive tear breakup time and meibomian gland score, as well as a greater decrease in OSDI score, with Systane iLux® versus mechanical expression. No adverse events were observed. The Systane iLux® MGD Thermal Pulsation System is a handheld in-office device that allows for application of localized heat and pressure while simultaneously visualizing the meibomian glands. Previous studies have demonstrated the ability of Systane iLux® to alleviate dry eye signs and symptoms in patients with MGD. Our study is the first to compare one Systane iLux® treatment session to a regimen of five in-office mechanical meibomian gland expression treatment sessions. The results indicate significant advantages with respect to signs and symptoms of dry eye and MGD over one year in subjects with moderate-to-severe baseline MGD. These findings provide additional evidence for the relative efficacy of Systane iLux® and its utility in treating MGD. © 2022 Alcon Inc. US-ILU-2200014