Woods Craig A, Bentley Sharon A, Fonn Desmond
Deakin Optometry, School of Medicine, Deakin University, Waurn Ponds, Australia.
Australian College of Optometry, National Vision Research Institute, University of Melbourne, Carlton, Australia.
Ophthalmic Physiol Opt. 2016 Nov;36(6):643-648. doi: 10.1111/opo.12318.
Contact lens discomfort continues to be reported as the primary reason for soft lens discontinuation, regardless of new modalities and materials. The purpose of this analysis of comfort related data from a series of clinical studies was to review whether there was a difference between symptomatic and asymptomatic habitual lens wearers' comfort responses over the course of the day.
Data from five independent non-dispensing clinical studies were pooled and analysed. Participants in these studies were assigned to one of two groups depending on whether they were classified as symptomatic or asymptomatic contact lens wearers according to a modified Subjective Evaluation of Symptoms of Dryness (SESOD) questionnaire. Masked participants were randomised to wear either a hydrogel or a silicone hydrogel contact lens and their ocular comfort was rated using a visual analogue scale on insertion and 2-hourly during an 8-hour period of a single lens wearing day.
Data from 103 participants were used, 58 in the symptomatic group and 45 in the asymptomatic group as determined by the SESOD questionnaire. There was no effect of lens material on comfort (p = 0.43). However, there was a significant interaction between symptoms and time. The difference in mean comfort between the symptomatic and asymptomatic group was significant at each time point (p < 0.05). However, comfort did not vary significantly over the day for the asymptomatic group (p = 0.87), whereas, there was a significant decline in mean comfort ratings for the symptomatic group from 84.6 ± 13.2 (S.D.) at insertion to 73.0 ± 18.5 at 8 hours (p < 0.001).
In our study, changes in contact lens comfort over a day were independent of lens material but not symptoms. Symptomatic lens wearers reported a progressive decrease in comfort, whereas asymptomatic wearers did not. Therefore, asymptomatic wearers should not be used when measuring contact lens comfort in clinical studies. The exclusion of asymptomatic lens wearers would likely increase the sensitivity of comfort ratings as a measure in contact lens research.
无论新的模式和材料如何，隐形眼镜不适仍然是软性隐形眼镜停用的主要原因。对一系列临床研究中与舒适度相关的数据进行分析的目的，是审查有症状和无症状的习惯性隐形眼镜佩戴者在一天中的舒适度反应是否存在差异。
汇总并分析了五项独立的非配镜临床研究的数据。根据改良的干眼症状主观评估（SESOD）问卷，这些研究的参与者被分为两组，即有症状或无症状的隐形眼镜佩戴者。被遮蔽的参与者被随机分配佩戴水凝胶或硅水凝胶隐形眼镜，并在佩戴单副隐形眼镜的8小时期间，于插入时和每2小时使用视觉模拟量表对其眼部舒适度进行评分。
使用了103名参与者的数据，根据SESOD问卷确定，有症状组58人，无症状组45人。镜片材料对舒适度没有影响（p = 0.43）。然而，症状和时间之间存在显著的交互作用。有症状组和无症状组之间的平均舒适度差异在每个时间点都很显著（p < 0.05）。然而，无症状组的舒适度在一天中没有显著变化（p = 0.87），而有症状组的平均舒适度评分从插入时的84.6±13.2（标准差）显著下降到8小时时的73.0±18.5（p < 0.001）。
在我们的研究中，一天中隐形眼镜舒适度的变化与镜片材料无关，但与症状有关。有症状的隐形眼镜佩戴者报告舒适度逐渐下降，而无症状的佩戴者则没有。因此，在临床研究中测量隐形眼镜舒适度时不应使用无症状佩戴者。在隐形眼镜研究中，排除无症状隐形眼镜佩戴者可能会提高舒适度评分作为一项指标的敏感性。
