■评估多频RF和IPL+MGX组合治疗睑板腺功能障碍(MGD)的疗效。
合格的受试者由于MGD而具有DED(干眼症)的体征和中度至重度症状。受试者以2周的间隔进行4次治疗。每种治疗包括强脉冲光(IPL),然后在眼周皮肤上进行射频(RF)。其次是睑板腺表达(MGX)。主要结果测量是沿着下眼睑的15个睑板腺的睑脂质量,使用修正的睑板腺评分(mMGS)。主要假设是基线(BL)和随访(FU)之间mMGS的减少。其他成果衡量标准,例如用OSDI(眼表疾病指数)问卷测量的症状,介体图,非侵入性泪液破裂时间(NIBUT),还评估泪液样品中的基质金属肽酶9(MMP-9)水平。
■31个科目完成了FU。在BL和FU之间,mMGS从30.4(8.5)降至9.3(9.5)(-69.3%,95%CI:-55.6%至-82.9%,p<0.0001);OSDI从63.6(17.2)降至25.0(20.6)(-60.7%,95%CI:-47.8%至-73.5%,p<0.0001);NIBUT没有变化(p=0.92)。构建具有历史对照的调整模型,以允许在不同研究中将这些受试者与用IPL+MGX(但没有RF)类似地治疗的那些受试者进行比较。该分析确定,当包括RF时,mMGS的变化更大(-20.9对-18.3,调整的p值(p_调整的)<0.05)。OSDI变化的差异不显着(-38.1vs-25.5,p-adjusted=0.196)。
■多频RF和IPL+MGX的组合可改善MGD的体征和症状。与历史控件相比,改进一般较大。需要进行一项随机对照研究,比较RF和IPL+MGX与单独的IPL+MGX的组合,以进一步阐述RF的相对贡献。
UNASSIGNED: To evaluate the efficacy of multi-frequency RF and IPL + MGX combination for treatment of Meibomian Gland Dysfunction (
MGD).
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.