The Berkeley Contact Lens Extended Wear Study. Part II : Clinical results.
The Berkeley Contact Lens Extended Wear Study. Part II : Clinical results.
复制标题
DOI：
10.1016/s0161-6420(01)00628-5
复制
发表时间：
2001-08
期刊：
影响因子：
13.7
通讯作者：
K. Polse;A. Graham;R. Fusaro;C. Gan;R. Rivera;M. Lin;T. L. Sanders;N. McNamara;J. S. Chan
中科院分区：
文献类型：
--
作者：
K. Polse;A. Graham;R. Fusaro;C. Gan;R. Rivera;M. Lin;T. L. Sanders;N. McNamara;J. S. Chan
目的描述与使用硬性透气性（RGP）长戴型隐形眼镜12个月相关的主要临床结果，并解决两个主要研究问题：（1）高透氧率（Dk/t）RGP镜片的长期配戴（EW）是否降低了眼部并发症的发生率，和（2）配戴高Dk/t镜片是否降低了12个月内维持6晚RGPEW的失败率？干预适应EW的高Dk受试者（透氧性）RGP镜片被随机分为高Dk或中Dk RGP镜片，进行12个月的6夜EW。主要结果测量接触镜片相关的角膜病变（CLAK），屈光不正和角膜曲率的变化，在EW中，201例受试者随机接受中等或高Dk镜片治疗12个月。每组中62%的受试者完成了12个月的EW;然而，中Dk组的失败概率显著更大。虽然两组的并发症风险相似，但导致终止的CLAK事件数量分别为16例和5例，中等Dk组和高Dk组分别为5例。这表明，不良反应的类型或无法扭转不良事件是不同的组暴露于较低的氧气dose. CONCLUSIONSTThe水平的氧气提供给角膜有显着的影响，保持成功的RGP延长接触透镜磨损，但不是在最初发作的CLAK。对于中等Dk组，导致终止的临床事件的数量显著更高，这表明角膜缺氧是CLAK发展的重要因素。尽管建议谨慎配戴过夜接触透镜，并仔细监测以早期发现眼部并发症，但对于大多数能够适应EW的个体而言，高Dk RGP镜片似乎是一种安全有效的屈光不正矫正治疗方法。
OBJECTIVETo describe the principal clinical outcomes associated with 12 months use of rigid gas-permeable (RGP) extended wear contact lenses and address two primary study questions: (1) does extended wear (EW) of high oxygen transmissibility (Dk/t) RGP lenses reduce the incidence of ocular complications, and (2) does the wearing of high-Dk/t lenses reduce the rate of failure to maintain 6-night RGPEW over 12 months?DESIGNA randomized, concurrently controlled clinical trial.INTERVENTIONSubjects who adapted to EW with high Dk (oxygen permeability) RGP lenses were randomized to either high Dk or medium-Dk RGP lenses for 12 months of 6-night EW.MAIN OUTCOME MEASURESContact lens-associated keratopathies (CLAK), changes in refractive error and corneal curvature, and survival in EW.RESULTSTwo hundred one subjects were randomized to medium or high-Dk lenses for 12 months of EW. Sixty-two percent of the subjects in each group completed 12 months of EW; however, the probability of failure was significantly greater for the medium-Dk group. Although the risk of complications was similar for the two groups, the number of CLAK events that led to termination were 16 versus 5 for the medium-Dk and high-Dk groups, respectively. This suggests that the type of adverse response or the inability to reverse an adverse event was different for the group being exposed to the lower oxygen dose.CONCLUSIONSThe level of oxygen available to the cornea has a significant impact on maintaining successful RGP extended contact lens wear, but not on the initial onset of CLAK. The number of clinical events leading to termination was substantially higher for the medium Dk group, which suggests that corneal hypoxia is an important factor in the development of CLAK. Although overnight contact lens wear should be recommended with caution and carefully monitored for early detection of ocular complications, it appears that high-Dk RGP lenses can be a safe and effective treatment for correction of refractive error for most individuals who can adapt to EW.