Zeid Mohamed Abo, Elrosasy Amr, Khalefa Kareem, Elhadary Mohamed, Mohamed Shrouk F, Elkelany Amr, Serhan Hashem Abu
Faculty of Medicine, Tanta University, Tanta, Egypt.
Medical Research Group of Egypt (MRGE), Negida Academy, Arlington, MA, USA.
Graefes Arch Clin Exp Ophthalmol. 2025 Mar 29. doi: 10.1007/s00417-025-06811-y.
This systematic review and meta-analysis aims to evaluate the efficacy and safety of the combination of phenylephrine 1% and ketorolac 0.3% (OMIDRIA®) for optimizing pain management and maintaining pupil dilation during cataract surgery. Comparisons were made against placebo/vehicle, phenylephrine alone, and epinephrine.
A comprehensive search of PubMed, Cochrane CENTRAL, Embase, Scopus, and Web of Science was conducted. Eligible studies were randomized clinical trials and observational studies assessing intracameral phenylephrine/ketorolac against control groups. Key outcomes included pain management, pupil diameter, and adverse events. Data were synthesized using meta-analysis with fixed and random-effects models, and heterogeneity was assessed using the I statistic.
Ten studies, including 220,061 patients, were analyzed. The combination of phenylephrine/ketorolac significantly reduced postoperative pain (RR = 0.72, 95% CI: 0.60-0.86) and opioid use (RR = 0.45, 95% CI: 0.23-0.89) compared to vehicle and epinephrine. PE/K also maintained a larger pupil diameter (MD = 0.54 mm, 95% CI: 0.32-0.75) with minimal heterogeneity (I = 0%) and reduced the incidence of severe pain (RR = 0.41, 95% CI: 0.27-0.63). No significant differences in adverse events such as elevated intraocular pressure, inflammation, or headaches were observed.
Phenylephrine/ketorolac (OMIDRIA®) demonstrates superior efficacy in maintaining intraoperative mydriasis, reducing postoperative pain, and minimizing opioid use without increasing adverse events. This combination offers a preferable alternative to traditional agents, potentially setting a new standard for pain management and pupil dilation in cataract surgery.
本系统评价和荟萃分析旨在评估1%去氧肾上腺素与0.3%酮咯酸联合使用（OMIDRIA®）在白内障手术中优化疼痛管理和维持瞳孔散大的有效性和安全性。与安慰剂/赋形剂、单独使用去氧肾上腺素以及肾上腺素进行了比较。
对PubMed、Cochrane CENTRAL、Embase、Scopus和Web of Science进行了全面检索。符合条件的研究为评估前房内注射去氧肾上腺素/酮咯酸与对照组比较的随机临床试验和观察性研究。主要结局包括疼痛管理、瞳孔直径和不良事件。使用固定效应模型和随机效应模型进行荟萃分析来综合数据，并使用I统计量评估异质性。
分析了10项研究，包括220,061名患者。与赋形剂和肾上腺素相比，去氧肾上腺素/酮咯酸联合使用显著减轻了术后疼痛（RR = 0.72，95%CI：0.60 - 0.86）和阿片类药物的使用（RR = 0.45，95%CI：0.23 - 0.89）。去氧肾上腺素/酮咯酸联合使用还维持了更大的瞳孔直径（MD = 0.54 mm，95%CI：0.32 - 0.75），异质性最小（I = 0%），并降低了严重疼痛的发生率（RR = 0.41，95%CI：0.27 - 0.63）。未观察到眼内压升高、炎症或头痛等不良事件有显著差异。
去氧肾上腺素/酮咯酸（OMIDRIA®）在维持术中瞳孔散大、减轻术后疼痛和减少阿片类药物使用且不增加不良事件方面显示出卓越的疗效。这种联合用药为传统药物提供了更好的替代方案，可能为白内障手术中的疼痛管理和瞳孔散大设定新的标准。
