Blackie Caroline A, Coleman Christy A, Holland Edward J
TearScience Inc., Morrisville, NC.
Cincinnati Eye Institute, Edgewood, KY, USA.
Clin Ophthalmol. 2016 Jul 26;10:1385-96. doi: 10.2147/OPTH.S109663. eCollection 2016.
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.
评估单次12分钟的矢量热脉动（VTP）治疗对改善睑板腺功能障碍和蒸发型干眼患者睑板腺功能及干眼症状的持续效果（长达1年）。
这项前瞻性、多中心、开放标签的临床试验纳入了200名受试者（400只眼），他们被随机分为单次VTP治疗组（治疗组）或每日两次、为期3个月的传统热敷及眼睑清洁治疗组（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、1、3、6、9和12个月时评估睑板腺分泌（MGS）和干眼症状的有效性指标。症状缓解不足的受试者在3个月（治疗组）和6个月（交叉组）后可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，治疗组86%的受试者仅接受了一次VTP治疗，MGS从基线时的6.4±3.7持续改善至17.3±9.1（P<0.0001），干眼症状从44.1±20.4改善至21.6±21.3（P<0.0001）；交叉组89%的受试者仅接受了一次VTP治疗，MGS从6.3±3.6持续改善至18.4±11.1（P<0.0001），干眼症状从49.1±21.0改善至24.0±23.2（P<0.0001）。MGS的更大平均改善与基线MGS较轻（P=0.0017）以及诊断与治疗之间的时间较短（P=0.0378）相关。
单次VTP治疗可在12个月内持续平均改善睑板腺功能并平均减轻干眼症状。与传统的每日两次、为期3个月的治疗方案相比，单次VTP治疗在睑板腺功能和干眼症状方面的平均改善显著更大。对睑板腺功能障碍进行早期VTP干预与更好的治疗效果相关。
