Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA; Department of Ophthalmology, Long School of Medicine, University of Texas Health at San Antonio, San Antonio, TX, USA.
Massachusetts Eye and Ear Infirmary, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.
Ocul Surf. 2020 Oct;18(4):852-856. doi: 10.1016/j.jtos.2020.08.008. Epub 2020 Aug 31.
Obstructive meibomian gland dysfunction (MGD) can be refractory to medical therapy. Intraductal meibomian gland (MG) probing may offer a potential therapeutic approach for these patients, but no randomized trials have been conducted to date.
To assess clinical changes after intraductal MG probing for patients with refractory obstructive meibomian gland dysfunction.
Randomized, double-masked, sham-controlled clinical trial.
Single-center, tertiary referral center.
42 patients with refractory obstructive MGD associated with lid tenderness.
Enrolled patients received one of the following treatments: 1) MG probing plus post-procedural topical sulfacetamide/prednisolone ointment (Blephamide®), 2) MG probing plus post-procedural lubricating ointment (GenTeal), or 3) sham probing plus GenTeal ointment. The probing was performed on the upper lids of both eyes.
Primary outcome measures were symptoms as measured by Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE), as well as tear break-up time (TBUT). Secondary outcome measures were other clinical signs. Safety of the procedure was also evaluated by investigating the treatment-related adverse events. At baseline and 4 weeks after the procedure a masked observer evaluated the following outcome measures: symptom questionnaires, including OSDI and SANDE, upper lid tenderness, lid margin telangiectasia, corneal fluorescein staining, conjunctival lissamine green staining, TBUT, Schirmer's test, and meibomian glands yielding liquid secretion (MGYLS).
Compared to baseline, the MG probing/Blephamide® group showed significant improvements in both OSDI and SANDE scores and the MG probing/GenTeal group demonstrated a significant improvement only in SANDE score. In contrast, the Sham/GenTeal group did not show any statistically significant changes in symptoms. There were no statistically significant changes in clinical signs in any group at the 4-week visit, except for improvement of lid tenderness in the sham probing group.
MG probing/Blephamide® results in a significant improvement in symptoms in patients with refractory obstructive MGD without any significant effect on clinical signs. Larger studies are warranted to determine the efficacy of MG probing.
Clinicaltrials.gov(identifier NCT02256969, Filed on 08/13/2014).
阻塞性睑板腺功能障碍（MGD）可能对药物治疗有抗性。 腔内睑板腺（MG）探查可能为这些患者提供一种潜在的治疗方法，但迄今为止尚无随机试验进行。
评估难治性阻塞性睑板腺功能障碍患者进行腔内 MG 探查后的临床变化。
随机，双盲，假对照临床试验。
单中心，三级转诊中心。
42 名患有与眼睑触痛相关的难治性阻塞性 MGD 的患者。
入组患者接受以下治疗之一：1）MG 探查加术后局部磺胺醋酰钠/泼尼松龙眼膏（Blephamide®），2）MG 探查加术后润滑眼膏（GenTeal），或 3）假探针加 GenTeal 眼膏。探查在上眼睑的双眼上进行。
主要观察指标是通过眼表面疾病指数（OSDI）和干眼症状评估（SANDE）以及泪膜破裂时间（TBUT）来衡量的症状。次要观察指标是其他临床体征。还通过调查与治疗相关的不良事件来评估该程序的安全性。在程序开始时和 4 周后，一位经过掩蔽的观察者评估了以下观察指标：症状问卷，包括 OSDI 和 SANDE，上眼睑压痛，睑缘毛细血管扩张，角膜荧光素染色，结膜丽丝胺绿染色，TBUT，Schirmer 测试和睑板腺产生液体分泌物（MGYLS）。
与基线相比，MG 探查/ Blephamide®组的 OSDI 和 SANDE 评分均有显著改善，而 MG 探查/ GenTeal 组仅 SANDE 评分有显著改善。相比之下，假探针/ GenTeal 组在症状上没有任何统计学上的显著变化。在第 4 周访视时，任何一组的临床体征均无统计学意义上的变化，除了假探针组的眼睑压痛改善。
MG 探查/Blephamide®可显著改善难治性阻塞性 MGD 患者的症状，而对临床体征无明显影响。需要更大的研究来确定 MG 探查的疗效。
Clinicaltrials.gov（标识符 NCT02256969，于 2014 年 8 月 13 日提交）。
