Eyeworld

EW RESIDENTS 106 October 2015 by Matthew Adams, MD, MBA, Shazia Ali, MD, Greg Brunin, MD, Robert Garoon, MD, Zaina Al-Mohtaseb, MD, and Mitchell Weikert, MD, Cullen Eye Institute, Baylor College of Medicine, Houston Review of "Intracameral phenylephrine and ketorolac surgery maintains intraoperative mydriasis and reduces – integrated results from two pivotal phase 3 studies" Cullen Eye Institute residents, from left to right: Shazia Ali, MD, Greg Brunin, MD, Robert Garoon, MD, and Matthew Adams, MD, MBA Source: Cullen Eye Institute A new intraoperative mydriatic and analgesic solution for cataract surgery became available this past year from Omeros. A paper reporting on the prospective randomized study appears in this month's JCRS and is reviewed by the Baylor residents. –David F. Chang, MD, EyeWorld journal club editor Zaina Al-Mohtaseb, MD, Associate program director, Cullen Eye Institute Purpose The purpose of this phase 3 mul- ticenter study was to evaluate the safety and efficacy of a combined phenylephrine and ketorolac intracameral injection drug on the maintenance of mydriasis during cataract surgery and in the reduction of postoperative ocular pain. Intraoperative miosis can compromise the surgical field and lead to sight threatening conditions such as anterior and posterior cap- sule tears, iris trauma, retained lens material, cystoid macular edema, zonular dehiscence, and vitreous loss. 1,2 A prospective study of sur- gical complications during cataract surgery found that the incidence of intraoperative complications, especially vitreous loss, was reduced by half when mydriasis was greater than 6 mm. 3 The emerging trend of femtosecond laser cataract surgery requires optical imaging, targeting, and laser delivery that may cause laser-induced miosis, which can impede the subsequent cataract removal. 2 Prostaglandin levels in the aqueous humor have been shown to increase during laser-assisted anterior capsulotomy, which can contribute to laser-induced miosis. 4 Products such as this may prove beneficial in this situation. In addi- tion, this study is important because a reduction in postoperative pain and inflammation results in higher patient satisfaction. Design This phase 3, multicenter, random- ized, parallel-group, double-masked, placebo controlled study was con- ducted with strict inclusion and ex- clusion criteria to eliminate possible confounding variables. The cohort was monitored for pupillary miosis during cataract surgery and surveyed for postoperative pain in the early and late postoperative periods. Pa- tients with a history of glaucoma or elevated intraocular pressures, ocular disease including pseudoexfoliation syndrome, or trauma were excluded. Additionally, patients were exclud- ed if they had recently used topical NSAIDs, phenylephrine, pilocarpine, mast cell stabilizers, or steroids. They were also excluded if they had also used oral medications including MAO-Is, corticosteroids, or alpha-1 adrenergic antagonists. Mitchell Weikert, MD, Residency program director, Cullen Eye Institute Introduction As one of the most common elective surgical procedures in the U.S., cataract extraction and intraocular lens placement comprises more than 10% of all outpatient sur- gical cases. Over the years, there have been many advancements in cataract extraction techniques including phacoemulsification and more recently the femtosecond laser, leading to precise and reproducible surgeries, as well as increased patient expectations. With the advent of these new technologies, patients expect better surgical outcomes with less pain and faster recovery times. This study aims to evaluate the effectiveness of OMS302 (Omidria [phenylephrine and ketorolac injec- tion] 1%/0.3%, Omeros, Seattle) in decreasing intraoperative miosis and postoperative pain. There are numerous intracamer- al mydriatic agents that are currently being used during cataract surgery, which may not be FDA approved and require compounding at special pharmacies. OMS302 is an FDA-ap- proved medication that is added to the intracameral irrigation solution used during cataract surgery.

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