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Abstract：
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).
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).
摘要：
阻塞性睑板腺功能障碍（MGD）可能是药物治疗的难治性。导管内睑板腺（MG）探查可能为这些患者提供潜在的治疗方法，但迄今为止尚未进行随机试验.
评估难治性梗阻性睑板腺功能障碍患者导管内MG探查后的临床变化。
随机化，双面蒙面,假对照临床试验。
单中心，三级转诊中心。
42例难治性梗阻性MGD患者伴有眼睑压痛。
纳入的患者接受了以下治疗之一：1）MG探查加术后局部舒法西坦/泼尼松龙软膏（布莱芬酰胺®），2)MG探测加术后润滑软膏(GenTeal),或3）假探查加GenTeal软膏。在双眼的上眼睑上进行探测。
主要结局指标是通过眼表疾病指数（OSDI）和干眼症状评估（SANDE）测量的症状，以及撕裂破裂时间（TBUT）。次要结果指标是其他临床体征。还通过调查治疗相关的不良事件来评估该程序的安全性。在基线和手术后4周，蒙面观察者评估了以下结果指标：症状问卷，包括OSDI和SANDE,上眼睑压痛，眼睑边缘毛细血管扩张症，角膜荧光素染色，结膜lisamine绿色染色，TBUT,Schirmer\'stest,和睑板腺产生液体分泌物（MGYLS）。
与基线相比，MG探查/Blephamide®组OSDI和SANDE评分均有显著改善,MG探查/GenTeal组仅SANDE评分有显著改善.相比之下,Sham/GenTeal组未出现任何统计学上显著的症状变化.在4周的随访中，任何组的临床体征均无统计学意义的变化，除了假探查组眼睑压痛改善。
MG探查/Blephamide®导致难治性阻塞性MGD患者的症状明显改善，对临床体征无任何显著影响。需要更大规模的研究来确定MG探查的疗效。
Clinicaltrials.gov（标识符NCT02256969，2014年8月13日提交）。
评估难治性梗阻性睑板腺功能障碍患者导管内MG探查后的临床变化。
随机化，双面蒙面,假对照临床试验。
单中心，三级转诊中心。
42例难治性梗阻性MGD患者伴有眼睑压痛。
纳入的患者接受了以下治疗之一：1）MG探查加术后局部舒法西坦/泼尼松龙软膏（布莱芬酰胺®），2)MG探测加术后润滑软膏(GenTeal),或3）假探查加GenTeal软膏。在双眼的上眼睑上进行探测。
主要结局指标是通过眼表疾病指数（OSDI）和干眼症状评估（SANDE）测量的症状，以及撕裂破裂时间（TBUT）。次要结果指标是其他临床体征。还通过调查治疗相关的不良事件来评估该程序的安全性。在基线和手术后4周，蒙面观察者评估了以下结果指标：症状问卷，包括OSDI和SANDE,上眼睑压痛，眼睑边缘毛细血管扩张症，角膜荧光素染色，结膜lisamine绿色染色，TBUT,Schirmer\'stest,和睑板腺产生液体分泌物（MGYLS）。
与基线相比，MG探查/Blephamide®组OSDI和SANDE评分均有显著改善,MG探查/GenTeal组仅SANDE评分有显著改善.相比之下,Sham/GenTeal组未出现任何统计学上显著的症状变化.在4周的随访中，任何组的临床体征均无统计学意义的变化，除了假探查组眼睑压痛改善。
MG探查/Blephamide®导致难治性阻塞性MGD患者的症状明显改善，对临床体征无任何显著影响。需要更大规模的研究来确定MG探查的疗效。
Clinicaltrials.gov（标识符NCT02256969，2014年8月13日提交）。
