Optimizing pain management and pupil dilation in cataract surgery: a systematic review and meta-analysis of phenylephrine/ketorolac (OMIDRIA)

Abstract

Purpose: 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. Methods: 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 I2 statistic. Results: 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 (I2 = 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. Conclusion: 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.