Ang Robert Edward T
Asian Eye Institute, 8th Floor PHINMA Plaza Bldg., Hidalgo Drive, Rockwell Center, 1200, Makati City, Philippines.
Cardinal Santos Medical Center, 10 Wilson St., Greenhills West, 1502, San Juan City, Philippines.
Ophthalmol Ther. 2025 Jul;14(7):1567-1579. doi: 10.1007/s40123-025-01167-2. Epub 2025 May 30.
Transepithelial photorefractive keratectomy (t-PRK) is an updated maneuver based on the proven surgical procedure of conventional photorefractive keratectomy (PRK) for the correction of ametropia. Unlike conventional PRK, which is a two-step process involving the physical removal of the corneal epithelium prior to excimer laser treatment of the stroma, t-PRK uses the excimer laser to complete both activities in a single-step procedure.
This was a prospective, randomized, controlled, contralateral, masked, single-surgeon study of adult subjects with myopia with a manifest residual spherical equivalent (MRSE) of ≤ 1.5 D or hyperopia with an MRSE of ≥ + 1.5 D, conducted at a single center in the Philippines. Eligible subjects were randomized to undergo conventional PRK in one eye and t-PRK in the other. The follow-up was for 6 months. The primary endpoint evaluated the absolute refractive predictability at 3 months. Secondary endpoints during the 6-month follow-up included safety, manifest refraction, visual acuity, halos and glare, slit-lamp examinations, and patient-reported outcomes.
A total of 35 subjects (70 eyes) were enrolled (63% female, 94% Asian, mean age 30 years). The mean (standard deviation [SD]) absolute prediction error was 0.26 D (0.23) for conventional PRK and 0.34 D (0.32) for t-PRK, meeting the threshold for demonstration of noninferiority (p = 0.2253). There were no statistically significant differences between conventional PRK and t-PRK for manifest sphere, manifest cylinder, MRSE, or uncorrected or corrected visual acuity at 6 months. All subjects were satisfied with both procedures and there was no preference for one treatment over the other.
Both conventional and t-PRK are equally safe and effective, and result in favorable outcomes for subjects with ametropia. The efficiency of the t-PRK procedure versus conventional PRK should be considered when PRK is indicated.
ClinicalTrials.gov, NCT04698174.
经上皮准分子激光角膜切削术（t-PRK）是基于已证实的传统准分子激光角膜切削术（PRK）手术方法改进而来的一种手术，用于矫正屈光不正。与传统PRK不同，传统PRK是一个两步过程，即在准分子激光治疗基质之前先物理去除角膜上皮，而t-PRK使用准分子激光在一步手术中完成这两个操作。
这是一项前瞻性、随机、对照、对侧、盲法、单术者研究，研究对象为菲律宾一个中心的成年近视患者，其明显残余球镜等效度（MRSE）≤1.5D或远视患者，其MRSE≥+1.5D。符合条件的受试者被随机分配，一只眼睛接受传统PRK，另一只眼睛接受t-PRK。随访6个月。主要终点评估3个月时的绝对屈光预测性。6个月随访期间的次要终点包括安全性、明显屈光、视力、光晕和眩光、裂隙灯检查以及患者报告的结果。
共纳入35名受试者（70只眼）（63%为女性，94%为亚洲人，平均年龄30岁）。传统PRK的平均（标准差[SD]）绝对预测误差为0.26D（0.23），t-PRK为0.34D（0.32），达到非劣效性证明阈值（p = 0.2253）。6个月时，传统PRK和t-PRK在明显球镜、明显柱镜、MRSE或未矫正或矫正视力方面无统计学显著差异。所有受试者对两种手术都满意，对一种治疗方法没有优于另一种的偏好。
传统PRK和t-PRK同样安全有效，对屈光不正患者均能产生良好效果。当需要进行PRK时，应考虑t-PRK手术与传统PRK相比的效率。
ClinicalTrials.gov，NCT04698174。
