The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye.
The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye.
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DOI：
10.2147/opth.s109663
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发表时间：
2016
期刊：
影响因子：
--
通讯作者：
Holland EJ
中科院分区：
文献类型：
--
作者：
Blackie CA;Coleman CA;Holland EJ
评价在睑板腺功能障碍和蒸发性干眼患者中，单次12分钟向量热脉冲（VTP）治疗在改善睑板腺功能和干眼症状方面的持续效果（长达1年）。前瞻性、多中心、开放标签临床试验包括200名受试者（400只眼），他们被随机分配至单次VTP治疗（治疗组）或每日两次、为期3个月的常规热敷和眼睑卫生治疗（对照组）。对照组受试者在3个月时接受交叉VTP治疗（交叉组）。在基线和1、3、6、9和12个月时评价睑板腺分泌（MGS）和干眼症状的有效性指标。症状缓解不充分的受试者可在3个月（治疗组）和6个月（交叉组）后接受额外的睑板腺功能障碍治疗。在3个月时，与对照组相比，治疗组在MGS（P<0.0001）和干眼症状（P=0.0068）方面的平均改善更大。在12个月时，86%的治疗组仅接受了一次VTP治疗，MGS平均改善从6.4±3.7（基线）至17.3±9.1干眼症从44.1±20.4降至21.6±21.3（P<0.0001）（P<0.0001）; 89%的交叉组仅接受过一次VTP治疗，MGS的持续平均改善从6.3±3.6提高到18.4±11.1干眼症由49.1±21.0降至24.0±23.2（P<0.0001）。MGS的平均改善越大，基线MGS的严重程度越低（P=0.0017），诊断和治疗之间的持续时间越短（P=0.0378）。单次VTP治疗可在12个月内持续平均改善睑板腺功能和平均减少干眼症症状。与常规的每日两次、为期3个月的治疗方案相比，单次VTP治疗对睑板腺功能和干眼症状的平均改善显著更大。睑板腺功能障碍的早期VTP干预与改善治疗结果相关。
To evaluate the sustained effect (up to 1 year) of a single, 12-minute vectored thermal pulsation (VTP) treatment in improving meibomian gland function and dry eye symptoms in patients with meibomian gland dysfunction and evaporative dry eye. The prospective, multicenter, open-label clinical trial included 200 subjects (400 eyes) who were randomized to a single VTP treatment (treatment group) or twice-daily, 3-month, conventional warm compress and eyelid hygiene therapy (control group). Control group subjects received crossover VTP treatment at 3 months (crossover group). Effectiveness measures of meibomian gland secretion (MGS) and dry eye symptoms were evaluated at baseline and 1, 3, 6, 9, and 12 months. Subjects with inadequate symptom relief could receive additional meibomian gland dysfunction therapy after 3 (treatment group) and 6 months (crossover group). At 3 months, the treatment group had greater mean improvement in MGS (P<0.0001) and dry eye symptoms (P=0.0068), compared to controls. At 12 months, 86% of the treatment group had received only one VTP treatment, and sustained a mean improvement in MGS from 6.4±3.7 (baseline) to 17.3±9.1 (P<0.0001) and dry eye symptoms from 44.1±20.4 to 21.6±21.3 (P<0.0001); 89% of the crossover group had received only one VTP treatment with sustained mean improvement in MGS from 6.3±3.6 to 18.4±11.1 (P<0.0001) and dry eye symptoms from 49.1±21.0 to 24.0±23.2 (P<0.0001). Greater mean improvement in MGS was associated with less severe baseline MGS (P=0.0017) and shorter duration of time between diagnosis and treatment (P=0.0378). A single VTP treatment can deliver a sustained mean improvement in meibomian gland function and mean reduction in dry eye symptoms, over 12 months. A single VTP treatment provides significantly greater mean improvement in meibomian gland function and dry eye symptoms as compared to a conventional, twice-daily, 3-month regimen. Early VTP intervention for meibomian gland dysfunction is associated with improved treatment outcomes.