Eyeworld

EW RESIDENTS 76 May 2017 by Edmund Tsui, MD, Tarika Thareja, MD, Nitish Mehta, MD, Anna Escuder, MD, Christopher Lo, MD, Priya Patel, MD, Laurence Sperber, MD and bisulfite-free intracameral 1.5% phenylephrine with a "certificate of sterility" compounded by an ac- credited pharmacy. 1 Alternatives to medically induced mydriasis include mechanical mydriasis with devices such as iris hooks or a Malyugin ring, however structural changes in the pupil can occur after use of these devices. Furthermore, postoperative pain is a common adverse effect of cataract surgery that decreases the quality of the patient's surgical ex- perience. Nonsteroidal anti-inflam- matory drugs inhibit prostaglandin release and are routinely used top- ically for the inhibition of surgical induced miosis and the treatment of pain and inflammation induced by cataract surgery. 2 OMS302 (Omidria [phenyl- ephrine and ketorolac injection] 1% / 0.3%, Omeros, Seattle) was developed to provide a commer- cial solution to address both of the above clinical concerns. The drug is administered continuously intraca- merally as part of routine irrigation during cataract surgery. OMS302 demonstrated superiority to placebo in the maintenance of intraoper- ative mydriasis and reduction of postoperative pain in three large Phase 3 randomized, placebo-con- trolled multicenter clinical trials in which all subjects received standard preoperative topical mydriatic and anesthetic agents. 3,4 Herein we review a prospective trial by Donnenfeld et al. designed to compare OMS302 to vehicle, phenylephrine alone, and ketorolac alone to assess the contribution of each individual component to intra- operative mydriasis and postopera- tive pain. Study summary Participants in the study were recruited from 23 study sites throughout the United States un- dergoing unilateral primary cataract phacoemulsification with insertion of an acrylic lens. The exclusion criteria included hypersensitivity to phenylephrine or NSAIDs, presence of significant medical comorbidi- ties, eye pathology or infection in either eye, or use of corticosteroid, MAOI, NSAID, mast cell stabilizers, alpha-1-adrenergic antagonists, or any ocular medications. All patients were screened within 28 days prior to surgery and received pre-operative topical moxifloxacin 0.5% for 3 days in addition to the operative day. For preoperative mydriasis, patients received 3 administrations of only 1 drop of phenylephrine 2.5% and tropicamide 1% to the operative eye within 60 minutes prior to surgery. The subjects were randomized into four groups: irrigation solution with the balanced salt solution ve- hicle only, with phenylephrine only added, with ketorolac only added, or with OMS302 (a combination of phenylephrine and ketorolac). A scale measurement with millime- ter markers was placed by the iris plane prior to surgical incision and dilation was determined by video capture at 1-minute intervals by a masked reader. Postoperatively, the patients were all given oral acetaminophen Review of "OMS302 (intracameral ketorolac effect on intraoperative pupil diameter and in cataract surgery" Laurence Sperber, MD, Residency Program Director, Cornea Service Director, New York University School of Medicine The combination of phenylephrine and ketorolac (Omidria) is ap- proved for intracameral adminin- istration during cataract surgery. I asked the NYU residents to review this multicenter study analyzing its efficacy that appears in this month's JCRS. –David F. Chang, MD, EyeWorld journal club editor Background Innovations in the cataract ex- traction procedure have transformed this increasingly common yet technically challenging surgery into a refractive experience with accurate results and minimal postoperative pain. In order to achieve this goal, methods to minimize surgical complications should continually be evaluated. Adequate mydriasis, for example, is essential in reduc- ing surgical complications, such as posterior capsular rupture, zonular breaks, and vitreous loss, which can compromise the effectiveness of the procedure. Currently, the stan- dard method for mydriasis induc- tion includes preoperative topical phenylephrine and an intracameral injection of commercially prepared non-preserved, bisulfite-free epi- nephrine (1:4000) admixed with non-preserved 1% lidocaine or, more recently given national shortages, the ASCRS Cataract Clinical Com- mittee supported preservative-free From left to right: Edmund Tsui, MD, Anna Escuder, MD, Christopher Lo, MD, Priya Patel, MD, Tarika Thareja, MD, and Nitish Mehta, MD Source: Edmund Tsui, MD EyeWorld journal club

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