Adaptive effects of 30-night wear of hyper-O(2) transmissible contact lenses on bacterial binding and corneal epithelium: a 1-year clinical trial.
Adaptive effects of 30-night wear of hyper-O(2) transmissible contact lenses on bacterial binding and corneal epithelium: a 1-year clinical trial.
复制标题
佩戴 30 晚超 O(2) 透射性隐形眼镜对细菌结合和角膜上皮的适应性影响：一项为期 1 年的临床试验。
DOI：
10.1016/s0161-6420(01)00867-3
复制
发表时间：
2002
期刊：
影响因子：
13.7
通讯作者：
Cavanagh,HDwight
中科院分区：
文献类型：
--
作者：
Ren,DavidH;Yamamoto,Kazuaki;Ladage,PatrickM;Molai,Michael;Li,Ling;Petroll,WMatthew;Jester,JamesV;Cavanagh,HDwight
目的：探讨长时间配戴（EW）过程中透镜类型和透氧性对角膜上皮的影响。设计：前瞻性、随机、双盲、单中心、平行治疗组、为期1年的临床试验。参加者：178例患者完成了研究：（1）高氧软性透镜（6夜[N] EW）（n = 27）;（2）高氧软性透镜（6夜[N] EW，n = 33）或（30夜[N] EW，n = 66）;和（3）高氧硬性透气性透镜（RGP）（30夜[N] EW，n = 52）。干预措施：在基线、EW的1、3、6、9、12个月时，冲洗室收集脱落的角膜表面细胞、共焦显微镜检查和泪液收集。主要观察指标：（1）铜绿假单胞菌（PA）与脱落的角膜表面细胞结合;（2）中央上皮厚度;（3）浅表上皮细胞面积;（4）上皮表面细胞脱落;和（5）泪液乳酸脱氢酶。研究结果：定量证据表明，在软性透镜EW的前3个月，PA与人角膜脱落上皮细胞的结合增加;对照高氧试验透镜显示出显著更高的细菌结合（P < 0.05）。此后结合活性逐渐降低，并在9个月和12个月后恢复至基线水平。角膜上皮表面细胞增大，中央上皮变薄，脱落细胞减少（P < 0.05）。值得注意的是，有随后的部分适应性恢复细胞脱落和上皮厚度，但不是表面细胞大小。对于所有结局指标，连续配戴6 N和30 N hyper-O2 soft透镜之间无显著差异。重要的是，hyper-O2 RGP透镜配戴在1年内未显示PA结合显著增加。结论：本研究建立了三个重要的新发现：（1）超氧软透镜EW产生的PA结合显著低于低氧软透镜，超氧软透镜的PA结合与6 N和30 N EW无显著差异;（二）6个月后，所有软性透镜配戴者的适应性恢复显著，逐渐恢复到透镜前的PA结合水平，其他结果指标部分恢复对于所有测试镜片EW，除了表面单元尺寸;（3）hyper-O2 RGP透镜的30 N EW在1年内没有产生PA结合的显著增加。综上所述，这些结果表明，在临床使用中引入新的高氧透过性透镜材料可提供更安全的EW，未来的溃疡性感染性角膜炎流行病学研究应在任何发病率/风险分析中考虑透镜EW中的透镜类型和时间。
OBJECTIVE: To determine effects of lens type and oxygen transmissibility on human corneal epithelium during extended wear (EW). DESIGN: Prospective, randomized, double-masked, single-center, parallel treatment groups, 1-year clinical trial. PARTICIPANTS: One hundred seventy-eight patients completed the study: (1) high-O2soft lens (6-night [N] EW) (n = 27); (2) hyper-O2soft lens (6N-EW, n = 33) or (30N-EW, n = 66); and (3) hyper-O2rigid gas-permeable lens (RGP) (30N-EW, n = 52). INTERVENTION: Irrigation chamber to collect exfoliated corneal surface cells, confocal microscopy, and tear collection at baseline, 1, 3, 6, 9, 12 months of EW. MAIN OUTCOME MEASURES: (1) Pseudomonas aeruginosa (PA) binding to exfoliated corneal surface cells; (2) central epithelial thickness; (3) superficial epithelial cell area; (4) epithelial surface cell exfoliation; and (5) tear lactate dehydrogenase. RESULTS: Quantitative evidence demonstrated increased binding of PA to human exfoliated corneal epithelial cells during the first 3 months of soft lens EW; the control high-O2test lens showed significantly higher bacterial binding (P < 0.05). Binding activity gradually decreased thereafter and returned to baseline after 9 and 12 months. The corneal epithelium demonstrated enlargement of surface cell size, thinning of central epithelium, and a significant decrease in surface cell shedding (P < 0.05). Remarkably, there was subsequent partial adaptive recovery in cell shedding and epithelial thickness but not surface cell size. There was no significant difference between 6N and 30N continuous wear of the hyper-O2soft lens for all outcome measures. Importantly, hyper-O2RGP lens wear did not show significantly increased PA binding during 1 year. CONCLUSIONS: This study establishes three important new findings: (1) hyper-O2soft lens EW produces significantly less PA binding than the lower O2soft lens with no significant difference in PA binding with 6N versus 30N EW of the hyper-O2soft lens; (2) there is a remarkable adaptive recovery after 6 months with all soft lens wear with gradual return to prelens PA binding levels and partial recovery of other outcome measures for all test lenses EW except surface cell size; (3) 30N EW of the hyper-O2RGP lens produced no significant increases in PA binding over 1 year. Taken together, these results suggest that introduction of new hyper-O2transmissible lens materials into clinical use may offer safer EW, and future epidemiologic studies of ulcerative infectious keratitis should consider both lens type and time in lens EW in any incidence/risk analysis.