Wolffsohn James S, Mroczkowska Stephanie, Hunt Olivia A, Bilkhu Paramdeep, Drew Tom, Sheppard Amy
*BSc, PhD, FAAO †BSc, PhD ‡BEng, PhD Ophthalmic Research Group, Aston University, Aston Triangle, Birmingham, United Kingdom (JSW, OAH, PB, TD, AS); and School of Health Professions, Faculty of Health and Human Sciences, University of Plymouth, Plymouth, United Kingdom (SM).
Optom Vis Sci. 2015 Nov;92(11):1063-8. doi: 10.1097/OPX.0000000000000706.
To assess the surface tear breakup time and clinical performance of three daily disposable silicone hydrogel contact lenses over 16 hours of wear.
Thirty-nine patients (mean [± SD] age, 22.1 [± 3.5] years) bilaterally wore (narafilcon A, filcon II-3, and delefilcon A) contact lenses in a prospective, randomized, masked, 1-week crossover clinical trial. Tear film was assessed by the tear meniscus height (TMH), ocular/contact lens surface temperature dynamics, and lens surface noninvasive breakup time at 8, 12, and 16 hours of wear. Clinical performance and ocular physiology were assessed by subjective questionnaire, by high-/low-contrast logMAR (logarithm of the minimum angle of resolution) acuity, and through bulbar and limbal hyperemia grading. Corneal and conjunctival staining were assessed after lens removal.
Delefilcon A demonstrated a longer noninvasive breakup time (13.4 [± 4.4] seconds) than filcon II-3 (11.6 [± 3.7] seconds; p < 0.001) and narafilcon A (12.3 [± 3.7] seconds; p < 0.001). A greater TMH (0.35 [± 0.11] mm) was shown by delefilcon A than filcon II-3 (0.32 [± 0.10] seconds; p = 0.016). Delefilcon A showed less corneal staining after 16 hours of lens wear (0.7 [± 0.6] Efron grade) than filcon II-3 (1.1 [± 0.7]; p < 0.001) and narafilcon A (0.9 [± 0.7]; p = 0.031). Time was not a significant factor for prelens tear film stability (F = 0.594, p = 0.555) or TMH (F = 0.632, p = 0.534). Lens brand did not affect temperature (F = 1.220, p = 0.308), but it decreased toward the end of the day (F = 19.497, p < 0.001). Comfort, quality of vision, visual acuity and contrast acuity, and limbal grading were similar between the lens brands but decreased with time during the day (p < 0.05).
The tear breakup time over the contact lens surface differed between lens types and may have a role in protecting the ocular surface.
评估三种日抛型硅水凝胶隐形眼镜佩戴16小时后的表面泪膜破裂时间及临床性能。
39例患者(平均[±标准差]年龄,22.1[±3.5]岁)双侧佩戴(纳拉非康A、菲康II - 3和德利菲康A)隐形眼镜,进行一项前瞻性、随机、双盲、为期1周的交叉临床试验。在佩戴8小时、12小时和16小时时,通过泪液半月皱襞高度(TMH)、眼/隐形眼镜表面温度动态变化以及镜片表面无创破裂时间来评估泪膜。通过主观问卷、高/低对比度最小分辨角对数视力(logMAR)以及球结膜和角膜缘充血分级来评估临床性能和眼生理状况。在取下镜片后评估角膜和结膜染色情况。
德利菲康A的无创破裂时间(13.4[±4.4]秒)长于菲康II - 3(11.6[±3.7]秒;p<0.001)和纳拉非康A(12.3[±3.7]秒;p<0.001)。德利菲康A的TMH(0.35[±0.11]毫米)大于菲康II - 3(0.32[±0.10]秒;p = 0.016)。在佩戴镜片16小时后,德利菲康A的角膜染色(0.7[±0.6]埃弗龙分级)少于菲康II - 3(1.1[±0.7];p<0.001)和纳拉非康A(0.9[±0.7];p = 0.031)。时间对于镜片前泪膜稳定性(F = 0.594,p = 0.555)或TMH(F = 0.632,p = 0.534)不是一个显著因素。镜片品牌不影响温度(F = 1.220,p = 0.308),但在一天结束时温度会降低(F = 19.497,p<0.001)。不同品牌镜片之间的舒适度、视觉质量、视力和对比视力以及角膜缘分级相似,但在一天中随时间下降(p<0.05)。
不同类型镜片的隐形眼镜表面泪膜破裂时间不同,可能对眼表起到保护作用。