J Refract Surg. 2022 Nov;38(11):733-740. doi: 10.3928/1081597X-20221019-01. Epub 2022 Nov 1.
To evaluate the safety, efficacy, and predictability of photorefractive keratectomy (PRK) at least 4 years after primary laser in situ keratomileusis (LASIK) and compare it to the United States Food and Drug Administration (FDA) criteria.
This retrospective, single-site study compared patients who underwent PRK enhancement from 2014 to 2019 after primary LASIK to those who only underwent primary LASIK without re-treatment from the same time period. Patient demographics and clinical information were compared between the two groups. Visual outcomes and postoperative complications were evaluated in the enhancement group.
A total of 374 eyes with PRK enhancement were compared to 472 without re-treatment. Age, sex, surgical eye, and preoperative sphere, and spherical equivalent (SE) were significantly different between the enhancement and control groups ( < .05). At 12 months post-enhancement, 67% had uncorrected distance visual acuity (UDVA) of 20/20 or better, 98% had UDVA of 20/40 or better, and 0.4% of eyes lost at least two lines of corrected distance visual acuity (CDVA). A total of 83% and 98% of eyes were within ±0.50 and ±1.00 diopters of the target, respectively. Post-enhancement complications (n = 66) included dryness (6.1%), epithelial ingrowth (2.7%), and haze (2.7%).
Older age at the time of the primary LASIK, female sex, right surgical eye, and more myopic sphere and SE were risk factors for enhancement. Although PRK enhancements are considered off-label procedures, they produce favorable outcomes at 3 and 12 months postoperatively while meeting FDA benchmarks for safety, efficacy, and predictability. .
评估初次激光原位角膜磨镶术(LASIK)后至少 4 年行光折射性角膜切削术(PRK)的安全性、有效性和可预测性,并将其与美国食品和药物管理局(FDA)的标准进行比较。
这项回顾性、单中心研究比较了 2014 年至 2019 年期间行 PRK 增强术的患者(行初次 LASIK 后再次治疗)与同期仅行初次 LASIK 而未行再治疗的患者。比较两组患者的人口统计学和临床资料。评估增强组的视力结果和术后并发症。
共比较了 374 只行 PRK 增强术的眼和 472 只未行再治疗的眼。增强组和对照组之间,年龄、性别、手术眼别、术前球镜和等效球镜(SE)差异有统计学意义(<.05)。增强术后 12 个月,67%的患者未矫正远视力(UDVA)达到 20/20 或更好,98%的患者达到 20/40 或更好,0.4%的眼至少丧失两行矫正远视力(CDVA)。分别有 83%和 98%的眼在目标值±0.50 和±1.00 屈光度范围内。增强术后的并发症(n=66)包括干燥(6.1%)、上皮内植入(2.7%)和混浊(2.7%)。
初次 LASIK 时年龄较大、女性、右眼、更近视的球镜和 SE 是增强的危险因素。尽管 PRK 增强术被认为是超适应证的,但在术后 3 个月和 12 个月,它们可产生良好的效果,同时符合 FDA 的安全性、有效性和可预测性标准。