Moezzi Amir M, Varikooty Jalaiah, Schulze Marc, Ngo William, Lorenz Kathrine Osborn, Boree Danielle, Jones Lyndon W
*MSc, BOptom †MSc ‡PhD, Dipl Ing (AO), FAAO §OD, FAAO ∥OD, MS, FAAO **MS ††PhD, FCOptom, FAAO Centre for Contact Lens Research, School of Optometry and Vision Science, University of Waterloo, Waterloo, Ontario, Canada (AMM, JV, MS, WN, LWJ); and Johnson & Johnson Vision Care, Jacksonville, Florida (KOL, DB).
Optom Vis Sci. 2016 Jun;93(6):619-28. doi: 10.1097/OPX.0000000000000840.
To determine if the use of pigments or adding polyvinyl pyrrolidone during the fabrication of 1-DAY ACUVUE DEFINE (AD) brand contact lenses impacts open-eye corneal swelling compared with no lens wear (NLW).
A partial double-masked, randomized, bilateral crossover study was conducted in 24 Asian subjects using AD, 1-DAY ACUVUE DEFINE with Lacreon (ADL), NLW, and a control lens with no tint (1-DAY ACUVUE MOIST [AM]). Central corneal thickness was measured before insertion and immediately after removal after 8 ± 1 h of open-eye wear using an optical pachymeter in one eye. Corneal thickness along a 10-mm cord was measured in the contralateral eye using the Visante optical coherence tomographer (OCT). Corneal swelling was tested for noninferiority using a 5% margin. The endothelial bleb response was measured at baseline and 20 min after lens insertion using specular microscopy. Subjective grading of corneal staining and limbal/bulbar hyperemia were also monitored.
After 8 ± 1 h of open-eye wear, central corneal swelling across the study lenses with either optical pachymeter or OCT methods was negligible. Peripheral corneal swelling least-square mean differences with OCT were -0.03% (95% confidence interval [95% CI], -0.65 to 0.58%) and -0.26% (95% CI, -0.87 to 0.36%) between AD and ADL and the control lens (AM), respectively, and 1.67% (95% CI, 1.06 to 2.29%) and 1.45% (95% CI, 0.84 to 2.06%) between AD and ADL and NLW, respectively. No endothelial blebs were observed. No clinically significant differences were distinguished between the lenses and NLW for corneal staining and limbal/bulbar hyperemia.
After 8 ± 1 h of open-eye wear, central and peripheral corneal swelling along the horizontal meridian with AD, ADL, AM, and NLW were equivalent. These results confirm that the addition of polyvinyl pyrrolidone or pigments to etafilcon A to obtain a limbal ring design have no impact on corneal swelling or limbal/bulbar hyperemia during normal open-eye wear.
确定在1-DAY ACUVUE DEFINE（AD）品牌隐形眼镜制造过程中使用色素或添加聚乙烯吡咯烷酮与不佩戴隐形眼镜（NLW）相比，对睁眼状态下角膜肿胀的影响。
对24名亚洲受试者进行了一项部分双盲、随机、双侧交叉研究，使用AD、含Lacreon的1-DAY ACUVUE DEFINE（ADL）、NLW以及无染色的对照镜片（1-DAY ACUVUE MOIST [AM]）。使用光学厚度仪在一只眼睛睁眼佩戴8±1小时后插入前和取出后立即测量中央角膜厚度。使用Visante光学相干断层扫描仪（OCT）在对侧眼睛中测量沿10毫米弦长的角膜厚度。使用5%的界值检验角膜肿胀的非劣效性。使用镜面显微镜在基线和镜片插入后20分钟测量内皮小泡反应。还监测了角膜染色和角膜缘/球结膜充血的主观分级。
睁眼佩戴8±1小时后，使用光学厚度仪或OCT方法测量的所有研究镜片的中央角膜肿胀均可忽略不计。AD与ADL以及对照镜片（AM）之间，使用OCT测量的周边角膜肿胀最小二乘均值差异分别为-0.03%（95%置信区间[95%CI]，-0.65至0.58%）和-0.26%（95%CI，-0.87至0.36%），AD与ADL以及NLW之间分别为1.67%（95%CI，1.06至2.29%）和1.45%（95%CI，0.84至2.06%）。未观察到内皮小泡。在角膜染色和角膜缘/球结膜充血方面，各镜片与NLW之间未发现临床显著差异。
睁眼佩戴8±1小时后，AD、ADL、AM和NLW在水平子午线上的中央和周边角膜肿胀相当。这些结果证实，在etafilcon A中添加聚乙烯吡咯烷酮或色素以获得角膜缘环设计，在正常睁眼佩戴期间对角膜肿胀或角膜缘/球结膜充血没有影响。
