Brennan Noel A, Coles M-L Chantal, Connor Heather R M, McIlroy Robert G, Gavras Serge, Moody Kurt J, Henderson Terri
Brennan Consultants Pty Ltd., Melbourne, Australia.
Eye Contact Lens. 2008 Nov;34(6):317-21. doi: 10.1097/ICL.0b013e31818b7428.
To evaluate corneal endothelial bleb response to wear of silicone-hydrogel contact lenses in eyes of East Asian subjects.
A total of 24 subjects of East Asian origin, attended 3 separate sessions for a prospective, single-centre, trial. The following contact lenses were used: ACUVUE ADVANCE with HYDRACLEAR (ADVANCE, -3 dioptres), ACUVUE OASYS with HYDRACLEAR Plus (OASYS, -3 dioptres), Focus NIGHT & DAY (NIGHT & DAY, -3 dioptres) and SofLens 38 (+3 dioptres). A modified Balaam's crossover design was used to randomize presentation of sessions and contact lenses within sessions. Session 1 was a comparison between OASYS and SofLens 38 under closed eye conditions, session 2 was a comparison between ADVANCE and NIGHT & DAY under open eye conditions, and session 3 was a comparison between OASYS and NIGHT & DAY worn under closed eye conditions. Corneal endothelial images were captured with the Topcon SP-3000P noncontact Specular Microscope before lens wear, after 20 mins of wear with lenses on and 5 and 10 mins later after lens removal. Blebs were manually identified on these digital images by a masked observer. The area of blebs and total area under consideration were derived using ImageNet software and used to calculate percentage area of blebs. A boundary of equivalence of 1% was used as a clinically significant bleb area difference, and two-sided 95% confidence intervals were utilized to evaluate differences between lenses within each session.
In session 1, SofLens 38 produced a mean percentage area of blebs of 8.0% under closed eye conditions, which was significantly different to that produced by OASYS (1.6%). In session 2, both Advance and Night & Day produced a mean percentage bleb area of 0.4% under open eye conditions. In session 3, OASYS and NIGHT & DAY produced statistically similar mean percentage bleb areas of 1.7% and 2.0%, respectively.
The similarity of bleb responses induced by the silicone-hydrogel lenses under the tested wearing conditions is consistent with the proposition that increases in Dk/t above a certain level will produce minimal change in corneal physiologic conditions compared with that when no lens is worn.
评估东亚受试者佩戴硅水凝胶隐形眼镜后角膜内皮小泡反应。
共有24名东亚受试者参加了一项前瞻性单中心试验的3个不同阶段。使用了以下隐形眼镜:含HYDRACLEAR的ACUVUE ADVANCE(ADVANCE,-3屈光度)、含HYDRACLEAR Plus的ACUVUE OASYS(OASYS,-3屈光度)、Focus NIGHT & DAY(NIGHT & DAY,-3屈光度)和SofLens 38(+3屈光度)。采用改良的Balaam交叉设计对各阶段及各阶段内的隐形眼镜佩戴顺序进行随机化。第1阶段是在闭眼条件下比较OASYS和SofLens 38,第2阶段是在睁眼条件下比较ADVANCE和NIGHT & DAY,第3阶段是在闭眼条件下比较佩戴的OASYS和NIGHT & DAY。在佩戴镜片前、佩戴镜片20分钟后以及取下镜片5分钟和10分钟后,使用Topcon SP - 3000P非接触式角膜内皮显微镜采集角膜内皮图像。由一位不知情的观察者在这些数字图像上手动识别小泡。使用ImageNet软件得出小泡面积和所考虑的总面积,并用于计算小泡面积百分比。将1%的等效边界用作具有临床意义的小泡面积差异,使用双侧95%置信区间评估各阶段内不同镜片之间的差异。
在第1阶段,SofLens 38在闭眼条件下产生的小泡平均面积百分比为8.0%,与OASYS产生的(1.6%)有显著差异。在第2阶段,ADVANCE和NIGHT & DAY在睁眼条件下产生的小泡平均面积百分比均为0.4%。在第3阶段,OASYS和NIGHT & DAY产生的小泡平均面积百分比在统计学上相似,分别为1.7%和2.0%。
在所测试的佩戴条件下,硅水凝胶镜片引起的小泡反应相似,这与以下观点一致:与不佩戴镜片时相比,当Dk/t增加到一定水平以上时,角膜生理状况的变化将最小。