Efficacy and safety of intense pulsed light delivered by the C.STIM® for treatment of Meibomian gland dysfunction.

ABSTRACT

INTRODUCTION: Intense pulsed light (IPL) appears to be a promising treatment for Meibomian gland dysfunction (MGD), the most common cause of dry eye disease. C.STIM® is a new IPL device. We report the first safety and efficacy study in clinical practice. MATERIALS AND METHODS: Patients with moderate MGD treated with C.STIM® were included. Three IPL sessions were performed at D0, D15 and D45 with 4 shots per side (fluence of 8J/cm2). Clinical evaluation was performed at D0, D45 and M3 with several parameters BUT, OSDI and Oxford scales, meibomian gland evaluation (morphology, quality and expressibility of meibum). The Lacrydiag® imaging device was used for objective evaluation of interferometry, meibography, tear meniscus height and NIBUT. The primary endpoint was the change in NIBUT between D0 and M3. Data collection was retrospective. Longitudinal analysis and a non-parametric linear mixed-effects model (R software) were used for statistical analysis. RESULTS: Thirty-five patients were included. NIBUT increased significantly between D0 and M3, with a mean difference of 2.6seconds (95% CI 2.0; 3.1, P<0.001). The other parameters studied also changed significantly, except for meibography (percentage of loss and morphology) and tear meniscus height. No adverse event was noted. CONCLUSION: C.STIM® appears safe and effective in the treatment of MGD, although a randomized controlled trial is needed to validate these results.