Stern Judith, Wong Reginald, Naduvilath Thomas J, Stretton Serina, Holden Brien A, Sweeney Deborah F
The Cooperative Research Centre for Eye Research and Technology, and the Cornea and Contact Lens Research Unit at the School of Optometry, The University of New South Wales, Sydney, Australia.
Optom Vis Sci. 2004 Jun;81(6):398-406. doi: 10.1097/01.opx.0000135092.69383.fd.
To compare the clinical performance of silicone hydrogel lenses worn for 6- or 30-nights, with monthly replacement, for 3 years.
In this 3-year prospective clinical trial, 161 subjects were enrolled and 154 commenced extended wear. Clinical performance was assessed by comparing discontinuations and lens surface characteristics (front surface deposits, lens wettability, number of mucin balls), lens fitting performance (primary gaze movement, lens tightness), and physiologic parameters (limbal and bulbar redness, corneal and conjunctival staining, microcysts) and subjective parameters (ratings of comfort and vision) between groups.
Eighty-eight subjects remained in the study after 36 months. There were no differences in the probability of subjects surviving in either group, and the major cause of lens-related discontinuation in both groups was contact lens-induced papillary conjunctivitis. There were no clinically important differences in performance between wear schedules.
The long-term clinical performance of silicone hydrogels worn for 6- or 30-nights continuously was similar. Clinical markers of hypoxia were low in both groups, and the 6-night wear schedule was not superior to the 30-night wear schedule with regard to preventing lens spoilage, improving corneal physiology, or subjective symptoms of comfort and vision.
比较佩戴6晚或30晚且每月更换的硅水凝胶镜片3年的临床表现。
在这项为期3年的前瞻性临床试验中,招募了161名受试者,其中154名开始延长佩戴。通过比较两组之间的镜片停用情况和镜片表面特征(前表面沉积物、镜片润湿性、粘蛋白球数量)、镜片适配性能(主要注视运动、镜片贴合度)、生理参数(角膜缘和球结膜充血、角膜和结膜染色、微囊肿)以及主观参数(舒适度和视力评分)来评估临床表现。
36个月后,88名受试者仍留在研究中。两组受试者留存概率无差异,两组与镜片相关的停用主要原因均为隐形眼镜诱发的乳头性结膜炎。不同佩戴方案之间的性能无临床重要差异。
连续佩戴6晚或30晚的硅水凝胶镜片的长期临床表现相似。两组的缺氧临床指标均较低,在防止镜片损坏、改善角膜生理或舒适度及视力主观症状方面,6晚佩戴方案并不优于30晚佩戴方案。