Blackie Caroline A, Coleman Christy A, Nichols Kelly K, Jones Lyndon, Chen Peter Q, Melton Ron, Kading David L, O'Dell Leslie E, Srinivasan Sruthi
TearScience Inc., Morrisville, NC.
School of Optometry, The University of Alabama at Birmingham, AB, USA.
Clin Ophthalmol. 2018 Jan 17;12:169-183. doi: 10.2147/OPTH.S153297. eCollection 2018.
To evaluate the effect of a single vectored thermal pulsation (VTP) treatment in contact lens wearers with meibomian gland dysfunction (MGD) and dry eye symptoms.
The prospective, nonsignificant risk, open-label, randomized, multi-center clinical trial included 55 soft contact lens (SCL) wearers with MGD and evaporative dry eye. Subjects were randomized to the single VTP treatment group or an untreated control. The controls received a crossover VTP treatment at 3 months (crossover treatment group). Primary effectiveness measures were meibomian gland secretion (MGS) score and Standard Patient Evaluation of Eye Dryness (SPEED) that were evaluated at baseline, at 1 and 3 months post-VTP treatment, and at 1 month post-VTP treatment in the crossover treatment group. Exploratory variables included fluorescein tear break-up time (TBUT), lid wiper epitheliopathy (LWE), lid parallel conjunctival folds (LIPCOF), ocular surface staining, frequency of over-the-counter (OTC) drop use, and hours of comfortable contact lens wear.
At 3 months, the treatment group showed significantly greater mean change from baseline in MGS (12.4±9.1 vs 1.4±6.4, p<0.0001), SPEED (-8.4±4.7 vs -0.7±4.4, p<0.0001) and significantly greater improvement in exploratory variables (TBUT, LWE, and frequency of OTC drop use) relative to the controls. Mean comfortable contact lens wearing time increased by 4.0±3.9 hours at 1 month. This was sustained for 3 months with no change in the control group. The crossover treatment group demonstrated similar results to the treatment group at 1 month post-VTP.
In SCL wearers with MGD, a single VTP treatment significantly improved mean meibomian gland function and significantly reduced dry eye signs and symptoms compared to an untreated control. The treatment increased mean comfortable lens wearing time by 4 hours (approximately doubling the pretreatment findings). This was sustained for up to 3 months post-treatment on average.
评估单次矢量热脉动(VTP)治疗对患有睑板腺功能障碍(MGD)和干眼症状的隐形眼镜佩戴者的效果。
这项前瞻性、低风险、开放标签、随机、多中心临床试验纳入了55名患有MGD和蒸发型干眼的软性隐形眼镜(SCL)佩戴者。受试者被随机分为单次VTP治疗组或未治疗对照组。对照组在3个月时接受交叉VTP治疗(交叉治疗组)。主要疗效指标为睑板腺分泌(MGS)评分和干眼标准患者评估(SPEED),在基线、VTP治疗后1个月和3个月以及交叉治疗组VTP治疗后1个月进行评估。探索性变量包括荧光素泪膜破裂时间(TBUT)、睑缘上皮病变(LWE)、睑结膜平行皱襞(LIPCOF)、眼表染色、非处方(OTC)滴眼液使用频率以及舒适佩戴隐形眼镜的时长。
在3个月时,治疗组的MGS相对于基线的平均变化显著更大(12.4±9.1对1.4±6.4,p<0.0001),SPEED也显著更大(-8.4±4.7对-0.7±4.4,p<0.0001),并且相对于对照组,探索性变量(TBUT、LWE和OTC滴眼液使用频率)有显著更大的改善。在1个月时,平均舒适佩戴隐形眼镜的时长增加了4.0±3.9小时。这种情况持续了3个月,而对照组没有变化。交叉治疗组在VTP治疗后1个月显示出与治疗组相似的结果。
在患有MGD的SCL佩戴者中,与未治疗的对照组相比,单次VTP治疗显著改善了平均睑板腺功能,并显著减轻了干眼体征和症状。该治疗使平均舒适佩戴镜片时长增加了4小时(约为治疗前结果的两倍)。平均而言,这种情况在治疗后可持续长达3个月。