Effects of daily and overnight wear of a novel hyper oxygen-transmissible soft contact lens on bacterial binding and corneal epithelium - A 13-month clinical trial
Effects of daily and overnight wear of a novel hyper oxygen-transmissible soft contact lens on bacterial binding and corneal epithelium - A 13-month clinical trial
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DOI：
10.1016/s0161-6420(02)01278-2
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发表时间：
2002-11-01
期刊：
影响因子：
13.7
通讯作者：
Jester, JV
中科院分区：
文献类型：
--
作者：
Cavanagh, HD;Ladage, PM;Jester, JV
目的：前瞻性测试先进的超透氧镜片 (HOTL) 的新生物学原理，为更安全地日常 (DW) 或长期 (EW) 隐形眼镜佩戴提供前景。设计：前瞻性、随机、双盲、单中心、13 个月的临床试验。参与者：168 名患者完成了 DW 研究（1 个月）：对照镜片（n = 70）； HOTL（n = 98）。 136 名患者完成了 1 年的 EW：对照（n = 56）、HOTL（n = 25、6 晚；n = 55、30 晚）。测试：冲洗室收集角膜表面细胞、共聚焦显微镜、基线、第 2 和 4 周的 DW 以及 24 小时、1、3、6、9 和 12 个月的 EW。结果测量：（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(CET)； (3)表面细胞面积(SCA)； (4)上皮表面细胞剥脱术(DESQ)； (5) 泪液乳酸脱氢酶 (LDH)。 结果：每日佩戴对照镜片可将 PA 结合力从每个细胞 5.90 +/- 2.60 细菌增加到 7.81 +/- 3.04 个细菌（P < 0.01）； HOTL 磨损增加的 PA 结合显着减少 (5.31 +/- 1.87-5.98 +/- 2.26; P < 0.01)。日常佩戴不会对 CET 或 SCA 产生显着变化。两种镜片的 DESQ 均显着下降，组间无显着差异。与对照组相比，HOTL 磨损的 DW 中泪液 LDH 显着增加（P = 0.0017），但在随后的 EW 1 个月后没有增加（P = 0.533）。使用对照镜片进行 EW 1 至 3 个月后，PA 结合力显着高于 HOTL 佩戴 (P < 0.01)；此后结合适应性下降，在 9 至 12 个月时恢复到基线。镜片 EW 导致 SCA 显着增大，CET 变薄（6 晚 HOTL 佩戴除外），DESQ 降低（P < 0.01）。 CET 和 DESQ 可以实现一定的适应性恢复，但 SCA 则不能；重要的是，数据表明 6 晚或 30 晚 EW 的所有结果均无显着差异。结论：与对照镜片佩戴相比，超透氧镜片佩戴（DW 或 EW）产生的 PA 结合显着降低，佩戴时间没有显着差异（6 晚与 30 晚）；此外，在所有软镜佩戴的前 6 个月内，出现了显着且出乎意料的适应性恢复，PA 结合水平恢复到基线，并且除 SCA 之外的其他结果在 1 年时部分恢复。这些结果表明，HOTL 的使用应会降低晶状体相关微生物性角膜炎的发病率和风险，并且进一步的流行病学研究应在未来的风险和发病率分析中考虑调整 EW 的时间。(c) 2002 年，美国眼科学会，Inc.
Objective: To test prospectively a new biologic rationale for an advanced hyper oxygen-transmissible lens (HOTL) providing prospects for safer daily (DW) or extended (EW) contact lens wear.Design: Prospective, randomized, double-masked, single-center, 13-month clinical trial.Participants: One hundred sixty-eight patients completed the DW study (1 month): control lens (n = 70); HOTL (n = 98). One hundred thirty-six patients finished 1 year of EW: controls (n = 56), HOTL (n = 25, 6 nights; n = 55, 30 nights).Testing: Irrigation chamber to collect corneal surface cells, confocal microscopy, tear collection at baseline, 2, and 4, weeks of DW, and 24 hours, 1, 3, 6, 9, and 12 months of EW.Main Outcome Measures: (1) Pseudomonas aeruginosa (PA) binding to exfoliated corneal surface cells; (2) central epithelial thickness (CET); (3) superficial cell area (SCA); (4) epithelial surface cell exfoliation (DESQ); and (5) tear lactate dehydrogenase (LDH).Results: Daily wear with control lens increased PA binding from 5.90 +/- 2.60 to 7.81 +/- 3.04 bacteria per cell (P < 0.01); HOTL wear increased PA binding significantly less (5.31 +/- 1.87-5.98 +/- 2.26; P < 0.01). Daily wear produced no significant changes in CET or SCA. Significant decreases in DESQ were seen with both lenses with no significant intergroup differences. Tear LDH increased significantly in DW with HOTL wear versus control (P = 0.0017), but not after 1 month of subsequent EW (P = 0.533). One to 3 months of EW with control lens showed significantly higher PA binding than HOTL wear (P < 0.01); binding adaptively decreased thereafter, returning to baseline at 9 to 12 months. Lens EW produced significantly enlarged SCA, thinning of CET (except 6-night HOTL wear), and decreased DESQ (P < 0.01). Some adaptive recovery was seen with CET and DESQ, but not SCA; importantly, the data indicated no significant difference between 6- or 30-night EW for all outcomes.Conclusions: Hyper oxygen-transmissible lens wear (DW or EW) produced significantly decreased PA binding compared with control lens wear, with no significant difference in wearing schedule (6 nights vs. 30 nights); additionally, there was a remarkable and unexpected adaptive recovery in the first 6 months of all soft lens wear, with a return to baseline PA binding levels and partial recovery for the other outcomes except SCA at 1 year. These results suggest that HOTL use should result in a decrease in the incidence of and risk(s) for lens-related microbial keratitis and that further epidemiologic studies should consider time in adapted EW in future risk and incidence analyses.(c) 2002 by the American Academy of Ophthalmology, Inc.