Suiter B G, Twa M D, Ruckhofer J, Schanzlin D J
Shiley Eye Center, University of California San Diego, School of Medicine, La Jolla, California, USA.
Trans Am Ophthalmol Soc. 2000;98:51-5; discussion 55-7.
To compare correction of low myopia by intrastromal corneal ring segments (ICRS) and by laser in situ keratomileusis (LASIK) with respect to early visual recovery and refractive outcomes.
Eighty-two eyes implanted with ICRS in a phase III study for US Food and Drug Administration review were matched with 133 eyes treated with LASIK by criteria of age (> 18 years, < 65 years), preoperative myopia (-1.00 to -3.50 diopters [D]), astigmatism (< or = 1.00 D), single treatment, and attempted full correction. Examinations were performed preoperatively and postoperatively at days 1 and 7 and months 1 and 3. Visual acuity and manifest refraction data were collected retrospectively. Visual function scores were assigned, and summarized results were compared.
Uncorrected visual acuity was 20/20 or better at day 1 in 24% of eyes (20/82) after ICRS and in 55% of eyes (73/133) after LASIK, and at month 3 in 75% of eyes (58/77) after ICRS and in 67% of eyes (84/126) after LASIK. Spherical equivalent refraction at month 3 was within +/- 1.00 D of intended correction in 99% of eyes (76/77) after ICRS and in 96% of eyes (121/126) after LASIK. Excellent visual function scores were noted at month 3 in 90% of eyes (69/77) after ICRS and in 78% of eyes (98/126) after LASIK.
Patients treated with LASIK showed better uncorrected visual acuity immediately following surgery; however, beyond 1 month, patients treated with ICRS achieved better uncorrected visual acuity that continued to improve with time. Visual function scores indicate that ICRS eyes see at higher levels of uncorrected visual acuity than LASIK eyes do with the same refractive error. The ICRS and LASIK were comparable in the correction of mild myopia.
比较基质内角膜环片(ICRS)和准分子原位角膜磨镶术(LASIK)在矫正低度近视方面的早期视力恢复情况和屈光效果。
在一项用于美国食品药品监督管理局审评的III期研究中,对82只植入ICRS的眼睛,按照年龄(>18岁,<65岁)、术前近视度数(-1.00至-3.50屈光度[D])、散光度数(≤1.00 D)、单次治疗以及尝试完全矫正等标准,与133只接受LASIK治疗的眼睛进行匹配。在术前、术后第1天和第7天以及术后1个月和3个月进行检查。回顾性收集视力和显验光数据。分配视觉功能评分,并比较总结结果。
ICRS术后第1天,24%的眼睛(20/82)裸眼视力达到20/20或更好;LASIK术后为55%的眼睛(73/133)。ICRS术后3个月,75%的眼睛(58/77)裸眼视力达到20/20或更好;LASIK术后为67%的眼睛(84/126)。ICRS术后3个月,99%的眼睛(76/77)等效球镜度在预期矫正值的±1.00 D范围内;LASIK术后为96%的眼睛(121/126)。ICRS术后3个月,90%的眼睛(69/77)视觉功能评分为优秀;LASIK术后为78%的眼睛(98/126)。
LASIK治疗的患者术后立即裸眼视力更好;然而,1个月后,ICRS治疗的患者裸眼视力更好,且随时间持续改善。视觉功能评分表明,在相同屈光不正情况下,ICRS治疗的眼睛裸眼视力水平高于LASIK治疗的眼睛。ICRS和LASIK在矫正轻度近视方面具有可比性。