Transepithelial Versus Conventional PRK: A Randomized Controlled Study.

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2025-07-01 Epub Date: 2025-05-30 DOI:10.1007/s40123-025-01167-2

Robert Edward T Ang

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引用次数: 0

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov, NCT04698174.

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经上皮与常规PRK：一项随机对照研究。

简介：经上皮性光屈光性角膜切除术（t-PRK）是一种基于常规光屈光性角膜切除术（PRK）的最新手术方法，用于矫正屈光不正。与传统的PRK不同，传统的PRK是一个两步的过程，包括在准分子激光治疗基质之前物理移除角膜上皮，t-PRK使用准分子激光在一步程序中完成这两个活动。方法：这是一项前瞻性、随机、对照、对侧、蒙面、单手术研究，在菲律宾的一个中心进行，研究对象是明显残余球面等效(MRSE)≤1.5 D的近视或MRSE≥+ 1.5 D的远视成人受试者。符合条件的受试者随机接受一只眼常规PRK和另一只眼t-PRK。随访6个月。主要终点评估3个月时绝对屈光可预测性。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、裂隙灯检查和患者报告的结果。结果：共纳入35名受试者（70只眼），其中63%为女性，94%为亚洲人，平均年龄30岁。常规PRK的平均（标准差[SD]）绝对预测误差为0.26 D (0.23)， t-PRK的平均（标准差[SD]）绝对预测误差为0.34 D(0.32)，满足证明非劣效性的阈值（p = 0.2253）。常规PRK和t-PRK在6个月时的表球、表柱、MRSE、未矫正或矫正视力方面无统计学差异。所有的受试者对两种治疗方法都很满意，没有哪一种治疗方法优于另一种。结论：常规和t-PRK同样安全有效，对屈光不正患者有良好的治疗效果。当显示PRK时，应考虑t-PRK程序与常规PRK的效率。试验注册：ClinicalTrials.gov, NCT04698174。

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. 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