Geldis Julia R, Nichols Jason J
Ohio State University, College of Optometry, Columbus, OH 43210, USA.
Eye Contact Lens. 2008 Sep;34(5):261-5. doi: 10.1097/ICL.0b013e31817fa604.
The purpose of this report is to describe the impact of punctal occlusion in symptomatic dry eye contact lens wearers and the relation between subjective and objective outcomes.
This study was a randomized, controlled, double-masked, single center clinical trial. A previously described dry-eye questionnaire was used to determine subject eligibility. Tear interferometry was performed to evaluate prelens tear film thickness, contact lens center thickness, and postlens tear film thickness. Each subject was randomly assigned to receive the punctal plugs or a sham procedure. At the outcome examination, the subject completed the dry-eye questionnaire and answered one question rating the efficacy of the punctal plug treatment in addition to undergoing tear interferometry using an identical protocol as the first visit.
Nineteen subjects completed both visits of this study. There was a significant improvement in the dry-eye questionnaire scores from baseline to the outcome visit for both the plug (Z = -2.52, P=0.01) and sham groups (Z = -2.93, P=0.003). A significant increase in prelens tear film thickness occurred within the sham group from baseline to the outcome visit (Z = -1.96, P=0.05), but not for the punctal plug group. No other layers measured by interferometry were shown to change significantly for either group.
Results comparing the sham and plug groups were not significantly different from each other with regards to the questionnaire score and treatment benefit assessment, indicating either the treatment effect was not detected, although present, or punctal occlusion had no treatment effect at all.
本报告旨在描述泪点封闭对有症状的干眼隐形眼镜佩戴者的影响以及主观和客观结果之间的关系。
本研究为一项随机、对照、双盲、单中心临床试验。使用先前描述的干眼问卷来确定受试者的入选资格。进行泪膜干涉测量以评估镜片前泪膜厚度、隐形眼镜中心厚度和镜片后泪膜厚度。每位受试者被随机分配接受泪点塞或假手术。在结果检查时,受试者完成干眼问卷,并回答一个关于泪点塞治疗效果的问题,此外还按照与首次就诊相同的方案进行泪膜干涉测量。
19名受试者完成了本研究的两次就诊。泪点塞组(Z = -2.52,P = 0.01)和假手术组(Z = -2.93,P = 0.003)的干眼问卷评分从基线到结果就诊均有显著改善。假手术组从基线到结果就诊时镜片前泪膜厚度有显著增加(Z = -1.96,P = 0.05),但泪点塞组没有。干涉测量所测量的其他层在两组中均未显示有显著变化。
在问卷评分和治疗效益评估方面,假手术组和泪点塞组的结果彼此无显著差异,这表明要么未检测到治疗效果(尽管存在),要么泪点封闭根本没有治疗效果。