Abstract
PURPOSE: To evaluate the efficacy of multi-frequency RF and IPL + MGX combination for treatment of Meibomian Gland Dysfunction (MGD). PATIENTS AND METHODS: Eligible subjects had signs and moderate-to-severe symptoms of DED (Dry Eye Disease) due to MGD. Subjects underwent 4 treatments at 2-week intervals. Each treatment consisted of intense pulsed light (IPL) followed by radiofrequency (RF) on the periocular skin, followed by meibomian gland expression (MGX). The main outcome measure was the quality of meibum in 15 meibomian glands along the lower eyelid, using the modified Meibomian Gland Score (mMGS). The main hypothesis was a reduction of mMGS between the baseline (BL) and the follow-up (FU). Other outcome measures, such as symptoms measured with the OSDI (Ocular Surface Disease Index) questionnaire, meibography, non-invasive tear break-up time (NIBUT), and matrix metallopeptidase 9 (MMP-9) levels in tear samples were evaluated as well. RESULTS: 31 subjects completed the FU. Between BL and FU, mMGS decreased from 30.4 (8.5) to 9.3 (9.5) (-69.3%, 95% CI: -55.6% to -82.9%, p<0.0001); OSDI decreased from 63.6 (17.2) to 25.0 (20.6) (-60.7%, 95% CI: -47.8% to -73.5%, p<0.0001); NIBUT did not change (p=0.92). An adjusted model with a historical control was constructed to allow the comparison of these subjects with those treated similarly with IPL+MGX (but without RF) in a different study. This analysis identified that the change in mMGS was larger when RF was included (-20.9 vs -18.3, adjusted p-value (p_adjusted) <0.05). The difference in OSDI change was not significant (-38.1 vs -25.5, p_adjusted = 0.196). CONCLUSION: Combination of multi-frequency RF and IPL+MGX improves signs and symptoms of MGD. In comparison to a historical control, improvements were generally larger. A randomized controlled study comparing the combination of RF and IPL+MGX with IPL+MGX alone is required to further elaborate the relative contribution of RF.