Lipson Michael J, Musch David C
Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor, Michigan, USA.
Optom Vis Sci. 2007 Jul;84(7):593-7. doi: 10.1097/OPX.0b013e31811ece4a.
The purpose of this study is to contrast the clinical and vision-related quality of life outcomes between Synergeyes, a hybrid contact lens, and Bausch & Lomb Soflens 66 Toric contact lenses in a cross-over design. Also, to determine subject preference of one mode of lens wear over the other.
The Synergeyes lens has a central rigid gas permeable portion made of Paragon HDS100 material (paflufocon D) bonded to the nonionic hydrophilic skirt material of 27% water (PolyHEMA hem-iberfilcon A). The Soflens 66 Toric lens is made of a nonionic hydrophilic 66% water (alphafilcon A) material. Subjects age 18 years and older with spherical refractive error between -0.50 and -8.00 D and astigmatism correction of -0.75 to -3.50 D were randomly assigned to wear one mode of contact lens for 1 month then wear the alternate mode for 1 month. Follow-up visits were done at 1 and 4 weeks. Data gathered at these visits included high-contrast log MAR distance visual acuity, average wearing time, comfortable wearing time, over-refraction, and slit lamp observations for corneal edema, conjunctival hyperemia, and corneal staining. At each visit, subjects were asked to rate overall comfort, dryness, and comfortable wearing time. Subjects were asked to complete the NEI-RQL-42 questionnaire at the end of each lens wearing period. Upon completion of both lens wearing modes, subjects were asked to choose their preferred mode.
Fifty subjects completed the study; 22 (44%) preferred the Synergeyes lenses, and 28 (56%) preferred the Soflens 66 Toric soft lenses. Measured visual acuity was significantly better with the Synergeyes lenses. Of the 13 attributes analyzed in the RQL-42, a statistically significant difference between the two modes was found in only one category, "symptoms." In that category, subjects indicated fewer symptoms when wearing soft lenses. The subjects' ratings also showed significantly more comfort while wearing the soft toric lenses.
Bausch & Lomb Soflens 66 Toric lenses were more comfortable and were perceived to produce less symptoms of dryness, itchiness, and lens awareness than Synergeyes lenses. Synergeyes lenses gave better visual acuity than the soft toric lenses.
本研究旨在采用交叉设计对比混合型隐形眼镜Synergeyes与博士伦Soflens 66 Toric隐形眼镜的临床及视力相关生活质量结果。此外,确定受试者对一种镜片佩戴方式相较于另一种的偏好。
Synergeyes镜片有一个由Paragon HDS100材料(帕氟康D)制成的中央硬性透气部分,与含水量为27%的非离子亲水性裙边材料(聚甲基丙烯酸羟乙酯半纤维二甲基硅氧烷A)相连。Soflens 66 Toric镜片由含水量为66%的非离子亲水性材料(阿尔法氟康A)制成。年龄在18岁及以上、球镜屈光不正度数在-0.50至-8.00 D之间且散光矫正度数在-0.75至-3.50 D之间的受试者被随机分配佩戴一种隐形眼镜模式1个月,然后佩戴另一种模式1个月。在第1周和第4周进行随访。在这些随访中收集的数据包括高对比度对数MAR远视力、平均佩戴时间、舒适佩戴时间、复验光度以及裂隙灯观察角膜水肿、结膜充血和角膜染色情况。每次随访时,要求受试者对总体舒适度、干燥感和舒适佩戴时间进行评分。在每个镜片佩戴期结束时,要求受试者完成NEI-RQL-42问卷。在完成两种镜片佩戴模式后,要求受试者选择他们偏好的模式。
50名受试者完成了研究;22名(44%)偏好Synergeyes镜片,28名(56%)偏好Soflens 66 Toric软性镜片。Synergeyes镜片测得的视力明显更好。在RQL-42分析的13项属性中,两种模式之间仅在一个类别“症状”中存在统计学显著差异。在该类别中,受试者表示佩戴软性镜片时症状较少。受试者的评分还显示,佩戴软性散光镜片时舒适度明显更高。
博士伦Soflens 66 Toric镜片比Synergeyes镜片更舒适,且被认为产生的干眼、瘙痒和镜片感知等症状更少。Synergeyes镜片的视力比软性散光镜片更好。