Bergenske Peter, Long Bill, Dillehay Sally, Barr Joseph T, Donshik Peter, Secor Glenda, Yoakum John, Chalmers Robin L
Pacific University School of Optometry, Forest Grove, OR, USA.
Eye Contact Lens. 2007 Mar;33(2):74-80. doi: 10.1097/01.ICL.0000258591.35468.2c.
To summarize results of a 3-year clinical trial assessing subjective and objective experience with lotrafilcon A silicone hydrogel (SH) lenses for up to 30 nights of continuous wear or low-Dk/t daily-wear (LDW) hydrogel lenses.
Nineteen sites dispensed SH lenses to 317 subjects (286 current wearers and 31 new wearers) and 2-week replacement LDW lenses to 81 new wearers in a 3-year study.
For the SH cohort, limbal redness, conjunctival redness, and corneal neovascularization improved among 23%, 21%, and 13% of eyes, respectively (P<0.001), with no signs increasing significantly. For the LDW cohort, limbal redness, papillary conjunctivitis, and corneal staining increased among 11%, 21%, and 13% of eyes, respectively (P<0.02), with no signs improving significantly. The change in average spherical equivalent power was -0.03 diopters for the age-matched SH cohort and -0.40 diopters for the LDW cohort (P=0.007). During the 3 years, the SH group reported significantly less frequent dryness during and at the end of the day, redness, photophobia, lens awareness, and blurred vision. Significantly more LDW lens wearers reported frequent during-the-day and end-of-day dryness and blurred vision.
During the 3 years, lotrafilcon A lens wearers who wore their lenses continuously for up to 30 nights showed stable, long-term improvements in many signs of corneal health and symptoms along with less myopic progression versus daily wearers of low-Dk/t hydrogel lenses. Many biomicroscopy signs and symptoms worsened among neophytes wearing daily-wear low-Dk/t hydrogel lenses. The use of lotrafilcon A lenses may minimize many ocular changes from soft contact lens wear.
总结一项为期3年的临床试验结果,该试验评估了使用lotrafilcon A硅水凝胶(SH)镜片连续佩戴长达30晚或低透氧系数/日戴(LDW)水凝胶镜片的主观和客观体验。
在一项为期3年的研究中,19个研究点为317名受试者(286名现佩戴者和31名新佩戴者)分发了SH镜片,并为81名新佩戴者分发了每2周更换一次的LDW镜片。
对于SH组,分别有23%、21%和13%的眼睛的角膜缘发红、结膜发红和角膜新生血管情况有所改善(P<0.001),且无体征显著加重。对于LDW组,分别有11%、21%和13%的眼睛的角膜缘发红、乳头性结膜炎和角膜染色情况加重(P<0.02),且无体征显著改善。年龄匹配的SH组平均球镜等效度的变化为-0.03屈光度,LDW组为-0.40屈光度(P=0.007)。在3年期间,SH组报告在白天和白天结束时出现眼干、眼红、畏光、镜片感知和视力模糊的频率显著更低。显著更多的LDW镜片佩戴者报告白天和白天结束时频繁出现眼干和视力模糊。
在3年期间,连续佩戴lotrafilcon A镜片长达30晚的佩戴者在角膜健康和症状的许多体征方面显示出稳定、长期的改善,与低透氧系数/日戴水凝胶镜片的日佩戴者相比近视进展也更少。佩戴日戴型低透氧系数水凝胶镜片的新手的许多生物显微镜检查体征和症状恶化。使用lotrafilcon A镜片可能会使软性隐形眼镜佩戴引起的许多眼部变化降至最低。