McDonald M B, Carr J D, Frantz J M, Kozarsky A M, Maguen E, Nesburn A B, Rabinowitz Y S, Salz J J, Stulting R D, Thompson K P, Waring G O
Southern Vision Institute, New Orleans, Louisiana, USA.
Ophthalmology. 2001 Feb;108(2):309-16. doi: 10.1016/s0161-6420(00)00528-5.
To assess the safety and effectiveness of the Summit Autonomous LADARVision active tracking narrow beam excimer laser system for laser in situ keratomileusis (LASIK) correction of myopia and astigmatism.
A multicenter, prospective noncomparative case series.
This cohort consisted of 177 eyes corrected for spherical myopia up to -11 diopters (D) and 170 eyes corrected for myopia up to -11 D spherical equivalent with astigmatism up to -5 D.
Treatments were performed at four sites in the United States using a 6-mm optic zone for spherical myopes and a 5.5-mm optic zone with a 1-mm blend for astigmats.
Visual acuity, subjective refraction, vector analysis, subject satisfaction, intraocular pressure, complications, and adverse reactions.
Six-month follow-up was available on 157 spherical eyes and 113 astigmatic eyes. For spherical myopes, uncorrected visual acuity (UCVA) was 20/20 or better in 60.5%, 20/25 or better in 80.3%, and 20/40 or better in 93.9%. The mean spherical equivalent was -0.29 +/- 0.45 D with 75.2% +/- 0.50 D and 94.9% +/- 1.00 D of intended. A loss of two lines of best spectacle-corrected visual acuity (BSCVA) occurred in 0.6%, and no eyes lost greater than two lines of BSCVA. For astigmatic myopes, UCVA was 20/20 or better in 52.0%, 20/25 or better in 74.5%, and 20/40 or better in 94.1%. The mean spherical equivalent was -0.23 +/- 0.49 D with 75.2% +/- 0.50 D and 95.6% +/- 1.00 D of intended. A loss of two lines of BSCVA occurred in 0.9%, and no eyes lost greater than two lines of BSCVA. Vector analysis showed that 99% of the intended cylinder was corrected on average with a mean angle of error of 4.2 degrees. Refractive stability was achieved between 1 and 3 months in 97.5% of spherical eyes and 99.4% of astigmatic eyes and confirmed between 3 and 6 months in 100% of both spherical and astigmatic eyes.
Eyes treated for myopia up to -11 D of spherical equivalent with or without astigmatism up to -5 D show early refractive stability, good UCVA outcomes, no significant loss of BSCVA, accurate correction of astigmatism, and slight undercorrection without a change from the photorefractive keratectomy algorithm and with a single treatment.
评估Summit Autonomous LADARVision主动跟踪窄光束准分子激光系统用于准分子原位角膜磨镶术(LASIK)矫正近视和散光的安全性和有效性。
一项多中心、前瞻性非对照病例系列研究。
该队列包括177只矫正球镜近视达-11屈光度(D)的眼睛以及170只矫正球镜等效近视达-11 D且散光达-5 D的眼睛。
在美国的四个地点进行治疗,对于球镜近视患者使用6毫米的光学区,对于散光患者使用5.5毫米的光学区并带有1毫米的融合区。
视力、主观验光、矢量分析、患者满意度、眼压、并发症及不良反应。
对157只球镜眼和113只散光眼进行了6个月的随访。对于球镜近视患者,未矫正视力(UCVA)达到20/20或更好的比例为60.5%,达到20/25或更好的比例为80.3%,达到20/40或更好的比例为93.9%。平均球镜等效度数为-0.29±0.45 D,达到预期度数的75.2%±0.50 D以及94.9%±1.00 D。最佳矫正视力(BSCVA)下降两行的发生率为0.6%,且没有眼睛的BSCVA下降超过两行。对于散光近视患者,UCVA达到20/20或更好的比例为52.0%,达到20/25或更好的比例为74.5%,达到20/40或更好的比例为94.1%。平均球镜等效度数为-0.23±0.49 D,达到预期度数的75.2%±0.50 D以及95.6%±1.00 D。BSCVA下降两行的发生率为0.9%,且没有眼睛的BSCVA下降超过两行。矢量分析显示,平均矫正了99%的预期柱镜度数,平均角度误差为4.2度。97.5%的球镜眼和99.4%的散光眼在1至3个月时实现了屈光稳定,在3至6个月时,球镜眼和散光眼的屈光稳定率均为100%。
矫正球镜等效近视达-11 D、伴有或不伴有散光达-5 D的眼睛,经单次治疗后显示出早期屈光稳定、良好的UCVA结果、BSCVA无显著下降、散光矫正准确且欠矫轻微,且未改变光屈光性角膜切削术算法。