Cavanagh H Dwight, Ladage Patrick M, Li Susanna L, Yamamoto Kazuaki, Molai Mike, Ren David H, Petroll W Matthew, Jester James V
Department of Ophthalmology, The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390, USA.
Ophthalmology. 2002 Nov;109(11):1957-69. doi: 10.1016/s0161-6420(02)01278-2.
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.
Prospective, randomized, double-masked, single-center, 13-month clinical trial.
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).
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.
(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).
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.
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.
前瞻性地测试一种新型高透氧性镜片（HOTL）的生物学原理，为更安全的日戴（DW）或长戴（EW）型隐形眼镜佩戴提供前景。
前瞻性、随机、双盲、单中心、为期13个月的临床试验。
168名患者完成了日戴研究（1个月）：对照镜片组（n = 70）；HOTL组（n = 98）。136名患者完成了1年的长戴：对照组（n = 56），HOTL组（25名患者佩戴6晚；55名患者佩戴30晚）。
冲洗室收集角膜表面细胞，共聚焦显微镜检查，在基线、日戴2周和4周以及长戴24小时、1、3、6、9和12个月时收集泪液。
（1）铜绿假单胞菌（PA）与脱落角膜表面细胞的结合；（2）中央上皮厚度（CET）；（3）表层细胞面积（SCA）；（4）上皮表面细胞脱落（DESQ）；（5）泪液乳酸脱氢酶（LDH）。
对照镜片日戴使PA与每个细胞的结合从5.90±2.60增加到7.81±3.04个细菌（P < 0.01）；HOTL佩戴使PA结合增加明显较少（5.31±1.87 - 5.98±2.26；P < 0.01）。日戴对CET或SCA无显著影响。两种镜片均使DESQ显著降低，组间无显著差异。与对照相比，HOTL日戴使泪液LDH显著升高（P = 0.0017），但在随后1个月的长戴后未升高（P = 0.533）。对照镜片长戴1至3个月时PA结合显著高于HOTL佩戴（P < 0.01）；此后结合适应性降低，在9至12个月时恢复到基线水平。镜片长戴使SCA显著增大，CET变薄（6晚HOTL佩戴除外），DESQ降低（P < 0.01）。CET和DESQ有一定适应性恢复，但SCA没有；重要的是，数据表明6晚或30晚长戴在所有结果上无显著差异。
与对照镜片佩戴相比，高透氧性镜片佩戴（日戴或长戴）使PA结合显著降低，佩戴时间安排（6晚与30晚）无显著差异；此外，所有软性镜片佩戴的前6个月有显著且意外的适应性恢复，1年时PA结合水平恢复到基线，除SCA外其他结果部分恢复。这些结果表明，使用HOTL应能降低与镜片相关的微生物性角膜炎的发生率和风险，未来的流行病学研究在进行风险和发生率分析时应考虑长戴适应期时间。
