Brennan Noel A, Coles M-L Chantal, Connor Heather R M, McIlroy Robert G
Brennan Consultants Pty Ltd., 110 Auburn Rd, Auburn Village, Melbourne 3122, Australia.
Cont Lens Anterior Eye. 2007 May;30(2):108-18. doi: 10.1016/j.clae.2007.02.006. Epub 2007 Apr 8.
To evaluate the clinical performance of comfilcon A (Biofinity) during 12 months of continuous wear compared to other silicone-hydrogel lenses.
Forty-five subjects were fitted in one eye with the comfilcon A (test) lens. For 22 subjects, the other eye was fitted with lotrafilcon A (group A) and for the remaining 23 subjects the other eye was fitted with balafilcon A (group B). Twelve-month data are presented on 48 measured variables.
There were no serious adverse events during the course of the study. A total of 33 subjects completed the study, with only 4 discontinuations for lens-related reasons, spread proportionately between the lenses. On preference scales, the test lens was superior to both control lenses for comfort (p<0.05) and overall preference (p<0.05) and in group A for vision (p<0.05). On grading scales, the test lens scored better than both control lenses for overall comfort (p<0.1 for group A, p<0.05 for group B), comfort during the day (p<0.05), end-of-day comfort (p<0.05) and overall preference (p<0.05), and better in group A for general vision quality (p<0.01), night vision quality (p<0.01) and handling (p<0.05). All lenses performed to a comparable degree on the basis of microcysts and corneal staining. There were significant differences between lenses in producing limbal redness (p<0.05), bulbar conjunctival hyperemia (p<0.1) and conjunctival NaFl staining (p<0.01) with the control lens in group A showing the greatest effect and the control lens in group B the least.
Comfilcon A offers performance advantages over first generation silicone-hydrogel materials for continuous wear.
与其他硅水凝胶镜片相比，评估comfilcon A（Biofinity）连续佩戴12个月的临床性能。
45名受试者一只眼睛佩戴comfilcon A（测试）镜片。对于22名受试者，另一只眼睛佩戴lotrafilcon A（A组），其余23名受试者另一只眼睛佩戴balafilcon A（B组）。呈现了48个测量变量的12个月数据。
研究过程中未出现严重不良事件。共有33名受试者完成了研究，仅4人因镜片相关原因中断，在各镜片间分布比例相同。在偏好量表上，测试镜片在舒适度（p<0.05）和总体偏好（p<0.05）方面优于两种对照镜片，在A组中视力方面也更优（p<0.05）。在评分量表上，测试镜片在总体舒适度（A组p<0.1，B组p<0.05）、白天舒适度（p<0.05）、一天结束时的舒适度（p<0.05）和总体偏好（p<0.05）方面得分高于两种对照镜片，在A组中一般视觉质量（p<0.01）、夜间视觉质量（p<0.01）和易操作性（p<0.05）方面表现更好。所有镜片在微囊肿和角膜染色方面表现相当。各镜片在引起角膜缘发红（p<0.05）、球结膜充血（p<0.1）和结膜NaFl染色（p<0.01）方面存在显著差异，A组对照镜片影响最大，B组对照镜片影响最小。
与第一代硅水凝胶材料相比，Comfilcon A在连续佩戴方面具有性能优势。
