Waring G O, O'Connell M A, Maloney R K, Hagen K B, Brint S F, Durrie D S, Gordon M, Steinert R F
Department of Ophthalmology, Emory University, Atlanta, Ga, USA.
J Refract Surg. 1995 May-Jun;11(3):170-80.
Argon fluoride (193 nm) excimer laser photorefractive keratectomy for myopia is under evaluation by the United States Food and Drug Administration.
We report a consecutive prospective series of 100 patients (one eye per patient) treated as part of the Phase IIB FDA-approved protocol, with 80 patients followed for 1 year. Patients' ages ranged from 21 to 62 years (mean, 35 years). The Summit Technology, Inc ExciMed UV200LA with a 4.5-mm diameter ablation was used.
Baseline spherical equivalent refraction ranged from -2.00 to -6.90 diopters (D) (mean -4.60 D). Ninety-five percent of eyes reepithelialized by 72 hours. At 1 year, the difference between attempted and achieved correction was +/- 0.50 D for 42 eyes (53%) and +/- 1.00 D for 60 eyes (75%). During the first 6 months, there was a trend toward overcorrection and the majority of eyes showed some loss of initial refractive correction; 10 eyes (14%) changed by 1.00 D or more between 6 and 12 months. An uncorrected visual acuity of 20/25 or better was achieved by 50 eyes (63%) and 20/40 or better by 61 eyes (77%). Of the 10 eyes (12%) that lost two or more Snellen lines of spectacle-corrected or glare visual acuity, two had visual acuity of worse than 20/25. Central subepithelial corneal haze was absent to mild in 77 (96%) eyes at 12 months.
Excimer laser photorefractive keratectomy as performed in this study was generally effective and safe in reducing simple spherical myopia. Further studies of the effect of a larger diameter ablation zone, smoother transitional corneal contours, and the effect of postoperative topical corticosteroids may lead to further improvements in outcome.
美国食品药品监督管理局正在对用于治疗近视的氟化氩(193纳米)准分子激光屈光性角膜切削术进行评估。
我们报告了连续100例患者(每位患者一只眼)的前瞻性系列研究,这些患者作为美国食品药品监督管理局批准的IIB期方案的一部分接受治疗,其中80例患者随访了1年。患者年龄在21至62岁之间(平均35岁)。使用了Summit Technology公司的ExciMed UV200LA,其消融直径为4.5毫米。
基线等效球镜屈光度范围为-2.00至-6.90屈光度(D)(平均-4.60 D)。95%的眼睛在72小时内重新上皮化。在1年时,42只眼(53%)尝试矫正与实际矫正的差值为±0.50 D,60只眼(75%)为±1.00 D。在最初的6个月内,有过矫的趋势,大多数眼睛的初始屈光矫正有一定程度的丧失;10只眼(14%)在6至12个月之间变化了1.00 D或更多。50只眼(63%)的裸眼视力达到20/25或更好,61只眼(77%)达到20/40或更好。在10只(12%)失去两行或更多行眼镜矫正视力或眩光视力的眼中,有两只眼的视力低于20/25。12个月时,77只眼(96%)的中央角膜上皮下混浊为无至轻度。
本研究中进行的准分子激光屈光性角膜切削术在降低单纯性球面近视方面总体上有效且安全。对更大直径消融区、更平滑的角膜过渡轮廓以及术后局部使用皮质类固醇的效果进行进一步研究,可能会使治疗效果得到进一步改善。