Knorz M C, Wiesinger B, Liermann A, Seiberth V, Liesenhoff H
Department of Ophthalmology, Klinikum Mannheim, Germany.
Ophthalmology. 1998 May;105(5):932-40. doi: 10.1016/S0161-6420(98)95040-0.
This study evaluated the predictability, stability, and safety of laser in situ keratomileusis (LASIK) in myopia and myopic astigmatism.
The study design was a prospective, unmasked, nonrandomized clinical trial.
Participating were 25 patients with myopia (37 eyes) with astigmatism of less than 1.00 diopter (D), divided into 3 subgroups (-5.00 to -9.90 D, 8 eyes; -10.00 to -14.90 D, 10 eyes; -15.00 to -29.00 D, 19 eyes), and 37 patients with myopia (56 eyes) with corneal astigmatism of 1.00 to 4.50 D, divided into 3 subgroups (-5.00 to -9.90 D, 12 eyes; -10.00 to -14.90 D, 24 eyes; -15.00 to -29.00 D, 20 eyes).
LASIK was performed using the Automatic Corneal Shaper and the Keracor 116 excimer laser.
Visual acuity, manifest refraction, central corneal islands, ablation decentration, and patient satisfaction were measured.
At 12 months, predictability, regression between 1 and 12 months, uncorrected visual acuity (UCVA), loss of two or more lines of corrected visual acuity, and patient satisfaction of the spherical (toric) groups are reported. Subgroups -5.00 to -9.90 D: 100% (75%) +1.00 D; regression less than or equal to 1.00 D in 100% (91.7%); UCVA greater than or equal to 20/40 in 87.5% (70%); none lost two or more lines; 100% (84%) highly satisfied. Subgroups -10.00 to -14.90 D: 60% (78.3%) +/-1.00 D; regression less than or equal to 1.00 D in 100% (87%); UCVA greater than or equal to 20/40 in 77.8% (86.4%); 10% (4.3%) lost two lines; 90% (91%) highly satisfied. Subgroups -15.00 to -29.00 D: 38.9% (21.4%) +/-1.00 D; regression less than or equal to 1.00 D in 72.2% (64.3%); UCVA greater than or equal to 20/40 in 33.3% (40%); 5.6% (7.1%) lost two lines; 78% (50%) highly satisfied. Differences of predictability and change of manifest refraction between subgroups of -5.00 to -9.90 D and -15.00 to -29.00 D were statistically significant. Central islands (decentrations) were observed in 17% (5.6%) of eyes of the spherical and in 16% (4.1%) of the toric group. Overall, the corneal interface was visible in 8.2%.
The LASIK method used in this study showed stability of manifest refraction and adequate uncorrected central visual acuity in a large percentage of patients with myopia up to -15.00 D. Corneal stability was not as uniform. Central corneal islands were observed in a sizable minority of patients despite pretreatment. For myopia greater than 15.00 D, accuracy and patient satisfaction were sufficiently poor to advise against using the authors' treatment technique in these groups. Visually significant microkeratome and laser-related problems were noted in a smaller percentage of patients. Patients with astigmatism correction were less pleased with results than were patients who received spherical corrections.
本研究评估了准分子原位角膜磨镶术（LASIK）治疗近视及近视散光的可预测性、稳定性和安全性。
本研究设计为一项前瞻性、非盲、非随机临床试验。
25例近视患者（37只眼），散光小于1.00屈光度（D），分为3个亚组（-5.00至-9.90 D，8只眼；-10.00至-14.90 D，10只眼；-15.00至-29.00 D，19只眼）；37例近视患者（56只眼），角膜散光为1.00至4.50 D，分为3个亚组（-5.00至-9.90 D，12只眼；-10.00至-14.90 D，24只眼；-15.00至-29.00 D，20只眼）。
使用自动角膜板层刀和Keracor 116准分子激光进行LASIK手术。
测量视力、显验光、中央角膜岛、切削偏心及患者满意度。
报告了12个月时球形（散光）组的可预测性、1至12个月间的屈光度回退、裸眼视力（UCVA）、矫正视力下降两行或更多行以及患者满意度。-5.00至-9.90 D亚组：100%（75%）达到±1.00 D；100%（91.7%）屈光度回退小于或等于1.00 D；87.5%（70%）的UCVA大于或等于20/40；无患者矫正视力下降两行或更多行；100%（84%）高度满意。-10.00至-14.90 D亚组：60%（78.3%）达到±1.00 D；100%（87%）屈光度回退小于或等于1.00 D；77.8%（86.4%）的UCVA大于或等于20/40；10%（4.3%）患者矫正视力下降两行；90%（91%）高度满意。-15.00至-29.00 D亚组：38.9%（21.4%）达到±1.00 D；72.2%（64.3%）屈光度回退小于或等于1.00 D；33.3%（40%）的UCVA大于或等于20/40；5.6%（7.1%）患者矫正视力下降两行；78%（50%）高度满意。-5.00至-9.90 D亚组与-15.00至-29.00 D亚组之间的可预测性及显验光变化差异具有统计学意义。球形组17%（5.6%）的眼及散光组16%（4.1%）的眼观察到中央岛（偏心）。总体而言，8.2%的患者角膜界面可见。
本研究中使用的LASIK方法在大部分近视度数达-15.00 D的患者中显示出显验光的稳定性及足够的裸眼中央视力。角膜稳定性并非一致。尽管进行了预处理，但仍有相当一部分患者观察到中央角膜岛。对于近视度数大于15.00 D的患者，准确性和患者满意度较差，不建议在这些患者群体中使用作者的治疗技术。较少比例的患者出现了与微型角膜刀和激光相关的、具有视觉意义的问题。散光矫正患者对结果的满意度低于接受球形矫正的患者。
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