Eiferman R A, O'Neill K P, Forgey D R, Cook Y D
University of Louisville, Department of Ophthalmology and Visual Sciences, KY 40202.
Refract Corneal Surg. 1991 Sep-Oct;7(5):344-7.
Six eyes of six patients with myopia between -4.00 and -8.00 diopters underwent 193 nm Argon/fluoride excimer laser photorefractive keratectomy as part of a Phase II-A FDA Study. Six months after surgery, four of the six eyes had a spherical equivalent refraction within +/- 1.00 D; five eyes saw 22/30 or better without correction. All corneas demonstrated a faint reticulated subepithelial haze most visible by sclerotic scatter illumination. There were no episodes of delayed epithelial healing or recurrent erosions, and patients had no loss of contrast sensitivity, visual acuity under glare testing, or corneal sensation at the 3-month or 6-month visit. In this limited clinical trial, the excimer laser was capable of changing the refractive power of the cornea for correction of myopia. Long-term follow up of these patients will be necessary to determine the safety and efficacy of the procedure.
作为美国食品药品监督管理局（FDA）II - A期研究的一部分，6名近视度数在-4.00至-8.00屈光度之间的患者的6只眼睛接受了193纳米氩氟准分子激光屈光性角膜切削术。术后6个月，6只眼中有4只眼的等效球镜度在±1.00 D以内；5只眼在未矫正的情况下视力达到22/30或更好。所有角膜均表现出轻微的网状上皮下混浊，通过巩膜散射照明最为明显。没有出现上皮延迟愈合或复发性糜烂的情况，并且在3个月或6个月随访时，患者的对比敏感度、眩光测试下的视力或角膜感觉均未丧失。在这项有限的临床试验中，准分子激光能够改变角膜的屈光力以矫正近视。对这些患者进行长期随访对于确定该手术的安全性和有效性是必要的。
