伴有或不伴有地塞米松泪小管内植入的热脉动治疗睑板腺功能障碍:一项前瞻性、盲法试验。
Thermal Pulsation with or without Dexamethasone Intracanalicular Insert for Meibomian Gland Dysfunction: A Prospective, Masked Trial.
作者信息
Dierker Damon S, Hauswirth Scott G
机构信息
Eye Surgeons of Indiana, Indianapolis, IN, USA.
Department of Ophthalmology, Sue-Anschutz-Rodgers Eye Center, University of Colorado School of Medicine, Aurora, CO, USA.
出版信息
Clin Ophthalmol. 2022 May 12;16:1477-1485. doi: 10.2147/OPTH.S359719. eCollection 2022.
SIGNIFICANCE
Meibomian gland dysfunction (MGD) is among the most common causes of dry eye disease worldwide. Few studies have compared treatment options, and the basis for an evidentiary approach to MGD management is lacking. We have conducted a non-randomized trial evaluating the additive benefit of a recently developed therapy.
PURPOSE
To compare the efficacy of thermal pulsation therapy alone or combined with the dexamethasone intracanalicular insert (Dextenza) on the signs and symptoms of MGD.
METHODS
This was a prospective, patient-masked, sham-controlled, non-randomized trial. All subjects underwent thermal pulsation therapy using the LipiFlow system. The dexamethasone intracanalicular insert was placed in the inferior canaliculus of the more symptomatic eye (DEX group), while sham punctal dilation of the fellow eye was performed to preserve patient masking (SHAM group). Key outcomes were improvement in meibum expressibility at 1, 4, and 12 weeks and patient treatment preference at week 12.
RESULTS
Nineteen subjects underwent thermal pulsation therapy and received the DEX insert. Meibomian gland expressibility scores improved significantly in both groups at 1, 4, and 12 weeks, with significantly greater improvement in DEX eyes than SHAM eyes at 12 weeks (=0.027). Improvement from baseline in TBUT was significant at all time points in DEX eyes and only at week 4 in SHAM eyes, with significantly greater improvement in DEX eyes over SHAM eyes at week 12 (=0.028). Mean best-corrected visual acuity and intraocular pressure remained unchanged from baseline throughout follow-up in both groups, and no adverse events were noted. Combined therapy with DEX was preferred by 61% of subjects.
CONCLUSION
This study demonstrated a significant benefit of combining thermal pulsation therapy with the dexamethasone intracanalicular insert on signs of MGD including TBUT and meibomian gland expressibility score. Consequently, a majority of patients preferred combination therapy to thermal pulsation therapy alone.
意义
睑板腺功能障碍(MGD)是全球干眼疾病最常见的病因之一。很少有研究比较治疗方案,且缺乏循证方法管理MGD的依据。我们进行了一项非随机试验,评估一种最近开发的疗法的附加益处。
目的
比较单独热脉动疗法或联合地塞米松泪小管植入物(Dextenza)对MGD体征和症状的疗效。
方法
这是一项前瞻性、患者盲法、假手术对照、非随机试验。所有受试者均使用LipiFlow系统进行热脉动疗法。将地塞米松泪小管植入物置于症状较重眼的下泪小管(DEX组),而对另一只眼进行假泪点扩张以保持患者盲法(SHAM组)。主要结局指标为1周、4周和12周时睑脂排出能力的改善情况以及12周时患者的治疗偏好。
结果
19名受试者接受了热脉动疗法并植入了DEX。两组在1周、4周和12周时睑板腺排出能力评分均显著改善,12周时DEX组的改善明显大于SHAM组(P = 0.027)。DEX组泪膜破裂时间(TBUT)从基线的改善在所有时间点均显著,而SHAM组仅在第4周显著,12周时DEX组的改善明显大于SHAM组(P = 0.028)。两组在整个随访期间平均最佳矫正视力和眼压与基线相比均无变化,且未观察到不良事件。61%的受试者更喜欢联合DEX治疗。
结论
本研究表明,热脉动疗法联合地塞米松泪小管植入物对MGD体征(包括TBUT和睑板腺排出能力评分)有显著益处。因此,大多数患者更喜欢联合治疗而非单独的热脉动疗法。