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Pupil constriction reatment9/25/2023 In an effort to understand the impact of an FDA-approved intervention to prevent intraoperative miosis, I reviewed the literature to assess the rates of complications related to intraoperative miosis. Despite steady improvements in technology and techniques over the past several decades, miotic pupils are still associated with often underappreciated surgical complication rates. Even so, these cases will be longer, outcomes may be adversely affected, and additional costs will be incurred. 4 Fortunately, we know how to handle this phenomenon. One study documented that 25% of cataract surgery patients with no identified risk factors will experience intraoperative miosis. ![]() The Impact of Intraoperative Miosis on Cataract Surgery Complication RatesĪs cataract surgeons, we all have had to deal with intraoperative miosis. Reports of these studies presented at the annual meeting of the Association for Research in Vision and Ophthalmology and the American Society of Cataract Refractive Surgery help flesh out the product’s clinical utility and allow surgeons to assess a new method of risk mitigation and the opportunity for cost savings in cataract surgery. There has also been a closer look at evidence in the literature around the incidence of adverse events associated with intraoperative miosis. Early anecdotal reports on Omidria were positive, and some ophthalmologists, including those in high-volume cataract surgery settings, have now conducted their own case-controlled studies. Many doctors withhold judgment on new technology until they have the opportunity to try it in actual practice without the constraints of a clinical trial protocol. These results are compelling, but ophthalmic surgeons all understand the necessary limitations of registration trials. The pain score data are even more impressive when considering that patients using the agent received less treatment for pain, with 43% more control patients requiring postoperative pain medication. Half the number of control patients (7.2% vs 14.1%) reported moderate to severe pain at any time point up to 12 hours postsurgery, and 26% of treated patients reported being pain free compared to 17% in the control group. These studies also demonstrate that Omidria reduces postoperative pain for 10 to 12 hours after surgery. These results were highly statistically significant ( P. ![]() Only 2.1% of eyes treated with the product experienced pupillary constriction of 2.5 mm or greater compared to nearly 30% in the control group. 1-3Ī post hoc analysis of pooled results from the two phase 3 studies shows that just 4% of eyes treated with Omidria had a pupillary diameter of less than 6 mm at the time of lens implantation compared to 23% of eyes in the control cohort (both groups received standardized preoperative mydriatic and anesthetic treatment data on file with Omeros). The pivotal phase 3 clinical trials further confirm the product’s effectiveness. A prospective, randomized, double-masked, full-factorial trial shows, with statistical significance, that the agent is approximately fourfold more effective than intracameral phenylephrine at preventing miosis. The clinical trials that provided the basis for FDA approval demonstrate compelling evidence of its efficacy, but there is a mistaken perception that Omidria is comparable to using intracameral epinephrine or phenylephrine. It is also the only approved product that contains a nonsteroidal anti-inflammatory drug for intraocular use. Omidria (phenylephrine and ketorolac injection 1%/0.3% Omeros) is the only intraoperative drug FDA approved for maintaining pupillary size and reducing postoperative pain. ![]() How to Present RLE to Patients in Three Simple Steps The Quest for an Ocular Injectable Antibiotic Product Intraoperative Miosis in Cataract Surgery Residual Ametropia After Multifocal IOL and Failed Radial KeratotomyĬombining Laser Cataract Surgery and Phacoemulsificationĭiscussing Premium Surgical Options With Patients
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