Phenylephrine 40mg/4ml / Ketorolac 12mg/4ml solution for intraocular irrigation vials

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 I 2 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 (I 2 = 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.

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The maintenance of mydriasis throughout cataract extraction surgery and the control of ocular inflammation are crucial for successful surgical outcomes. The development of miosis during cataract surgery compromises the visualization of the surgical field and working space for surgeons. This may lead to complications that include posterior capsular tear and associated vitreous loss, longer surgical time, and postoperative inflammation. Postoperative inflammation is often uncomfortable and frustrating for patients. It causes pain, redness, and photophobia. This compromises the best-uncorrected vision following surgery and often leads to multiple clinic visits. This article examines the literature published on the current treatments used to manage mydriasis, pain, and inflammation in cataract extraction surgery. Combination phenylephrine/ketorolac injection offers an exciting new class of medication for use in cataract surgery. With the recent approval of Omidria™ (combination of phenylephrine 1% and ketorolac 0.3%) by the US Food and Drug Administration (FDA) for intraocular use, we review the clinical utility of this new combination injection in cataract surgery. PubMed, MEDLINE, and conference proceedings were searched for the relevant literature using a combination of the following search terms: cataract extraction surgery, pupil dilation (mydriasis), miosis, phenylephrine, ketorolac, Omidria™, intracameral mydriatic. Relevant articles were reviewed and their references checked for further relevant literature. All abstracts were reviewed and full texts retrieved where available.

Abstract licence: CC BY-NC

Objective The objective of this study was to assess the feasibility of using an intracameral phenylephrine/ketorolac infusion during cataract surgery as a single agent to prevent postoperative pain, inflammation, and other complications. Methods A prospective, single-group feasibility study was conducted in which phenylephrine/ketorolac infusion was administered during cataract surgery and no perioperative topical drops were initially prescribed. Patients underwent optical coherence tomography, corrected distance visual acuity testing, and slit lamp biomicroscopy examination at perioperative visits, during which they also reported symptoms of pain, irritation, and/or photophobia. A goal adverse event (AE) rate was set at ≤5.0%. Results A total of 94 eyes (60 patients) were included in this study. The AE rate was 13.8% (13/94 eyes) with pain/irritation in eight eyes, cystoid macular edema (CME) in three eyes, and corneal edema in three eyes. Conclusions Based on an AE rate goal of ≤5.0%, using intraoperative, intracameral phenylephrine/ketorolac alone was not deemed a feasible alternative to current postoperative eye drop regimens in our clinical setting. However, a 13.8% AE rate is comparable to the rates of postoperative CME, corneal edema, pain, and irritation in the published literature. Thus, more research is needed to truly define this approach as inferior or non-inferior to the current standard of care.

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PURPOSE: ) is used during cataract surgery to prevent intraoperative miosis and reduce postoperative pain. Although studied in beagles, no human data exist showing the duration ketorolac remains in the eye postoperatively. A clinical trial measuring ketorolac concentrations in aqueous/vitreous samples necessitated the development of a validation process for acquiring these measurements. Due to limited human aqueous/vitreous humor sample availability, a bioanalytical method was developed and validated to quantify ketorolac levels using human plasma as a surrogate matrix. METHODS: 5) from plasma as a surrogate for aqueous and vitreous humor using a protein precipitation sample preparation technique, followed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis. RESULTS: The validated method can be successfully applied for quantitation of ketorolac over a concentration range of 2.5 ng/mL to 5000 ng/mL. The method met the acceptance criteria with respect to selectivity, specificity, precision, accuracy, linearity, dilution integrity, and stability. CONCLUSIONS: The validated method can use plasma as a surrogate matrix for quantitation of ketorolac in aqueous and vitreous humor, thereby eliminating the need to procure human vitreous and aqueous samples for validation prior to initiation of a clinical trial.

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Phenylephrine, a potent sympathomimetic, induces mydriasis via iris dilator muscle contraction. Intracameral (IC) phenylephrine has been successfully used in cataract surgery for initial mydriasis, maintaining mydriasis, and management of intraoperative floppy-iris syndrome. Serious systemic adverse events (mainly cardiovascular) have been described with topical phenylephrine drops, but we found very little evidence of such adverse events associated with IC phenylephrine use. However, we suspect under-reporting of such adverse events, as they may instead be ascribed to anxiety, positioning, anesthesia, etc. Optimal dosage/concentrations for IC phenylephrine use in different purposes have not been fully studied. In the absence of robust evidence, we suggest that lower but effective IC phenylephrine concentrations are used: a lower concentration (0.31%), in conjunction with an anticholinergic and lidocaine, may be used for initial mydriasis. For management of intraoperative floppy-iris syndrome, 0.31% may be effective, though a higher concentration (1% to 1.25%) may be required.

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Background/Objectives: Balloon eustachian tuboplasty (BET) is an effective surgical option for obstructive eustachian tube dysfunction (OETD). However, the feasibility of performing BET under local anesthesia (LA) using simplified analgesic protocols remains underexplored. We examined the feasibility of a streamlined LA-BET protocol. Methods: Fifty patients (sixty-four ears) diagnosed with primary OETD between March 2024 and December 2025 were enrolled. All patients underwent BET under LA using intramuscular ketorolac and topical lidocaine gel without sedation or nerve blocks. Pain scores, blood pressure changes, and patient acceptance were analyzed for each patient; Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) scores, tympanogram types, and Valsalva results were analyzed for each ear. All outcome measures were assessed 3 months postoperatively. Results: The mean ETDQ-7 score significantly improved from 24.9 ± 7.4 to 11.9 ± 5.4 (p < 0.001). The minimal clinically important difference (MCID ≥ 3.7) was achieved in 90.6% of ears, and normalization (ETDQ-7 ≤ 14.5) in 75.0%. The proportion of ears with positive Valsalva maneuvers increased from 39.1 to 76.6% (p < 0.01), and type A tympanograms improved from 64.1 to 84.4% (p = 0.018). Mean pain scores were 3.5 during insertion, 2.1 during balloon inflation, and 0.6 after deflation. All patients completed the procedure, and 96% would undergo LA again. Conclusions: LA-BET performed using intramuscular ketorolac and topical lidocaine gel is safe, tolerable, and effective. This protocol provides symptom relief and functional improvement without sedation or nerve block and offers a practical outpatient alternative for chronic OETD management.

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ObjectiveThe pupils of children with retinoblastoma are routinely dilated pre procedure with Tropicamide and Phenylephrine. Despite that, the pupil constricts once general anesthesia begins. The aim of this study is to see if adding Ketorolac to the regular dilating drops given pre procedure shortens the length of anesthesia.MethodsRetrospective comparison of time under anesthesia for two groups of retinoblastoma children receiving anesthesia for examination under anesthesia: one group (2019-2022) had been dilated with Tropicamide 1% and Phenylephrine 2.5% while the second group (2022-23) was dilated with a combination drop using those drugs with topical Ketorolac 0.5% and Proparacaine 0.5%.ResultsAverage anesthesia time for patients who received the older two drug combination was 25 minutes vs. 16 minutes (36% reduction in exposure time) for those who received the newer four drug combination (9 minutes less anesthesia) (p<0.001).ConclusionsThe use of a combined dilating drop that incorporated Tropicamide 1%, Phenylephrine 2.5%, Proparacaine 0.5% and Ketorolac 0.5% significantly shortened the time for exams under anesthesia for children with retinoblastoma because the pupil remained dilated after anesthesia induction with Sevoflurane. Using this combined drop, children will receive 5-10 hours less anesthesia during their treatment for retinoblastoma and staff will have more than 150 hours fewer exposure to anesthetic gasses. In addition, far fewer drops are necessary pre anesthesia, minimizing trauma to the children and families. The pupils of children with retinoblastoma are routinely dilated pre procedure with Tropicamide and Phenylephrine. Despite that, the pupil constricts once general anesthesia begins. The aim of this study is to see if adding Ketorolac to the regular dilating drops given pre procedure shortens the length of anesthesia. Retrospective comparison of time under anesthesia for two groups of retinoblastoma children receiving anesthesia for examination under anesthesia: one group (2019-2022) had been dilated with Tropicamide 1% and Phenylephrine 2.5% while the second group (2022-23) was dilated with a combination drop using those drugs with topical Ketorolac 0.5% and Proparacaine 0.5%. Average anesthesia time for patients who received the older two drug combination was 25 minutes vs. 16 minutes (36% reduction in exposure time) for those who received the newer four drug combination (9 minutes less anesthesia) (p<0.001). The use of a combined dilating drop that incorporated Tropicamide 1%, Phenylephrine 2.5%, Proparacaine 0.5% and Ketorolac 0.5% significantly shortened the time for exams under anesthesia for children with retinoblastoma because the pupil remained dilated after anesthesia induction with Sevoflurane. Using this combined drop, children will receive 5-10 hours less anesthesia during their treatment for retinoblastoma and staff will have more than 150 hours fewer exposure to anesthetic gasses. In addition, far fewer drops are necessary pre anesthesia, minimizing trauma to the children and families.

Abstract licence: CC BY-NC-ND