Eyeworld

EW RESIDENTS 106 October 2018 EyeWorld journal club by Kenneth Taubenslag, MD, Tigran Kostanyan, MD, Jennifer Lee, MD, Anagha Medsinge, MD, Siwei Zhou, MD, Leonid Zlotcavitch, MD, Ian Conner, MD, PhD, and Evan Waxman, MD, PhD traction and after lens implantation was 0.67 ± 0.44 mm in treated eyes compared to 1.67 ± 0.82 mm in controls (p<0.1). Iris prolapse was seen significantly more often in con- trol eyes, occurring in 56% of cases compared to 12% in the treatment group. The control group also scored higher on the newly proposed iris billowing grading scale on average, though 60% of treated eyes still demonstrated what was character- ized as moderate iris billowing. No surgical complications occurred in either study group. There are no declared conflicts of interest, and Omeros did not sponsor the study. However, a search of Centers for Medicare and Medic- aid Services (CMS) open payments data from 2015–2017 does show that Dr. Silverstein has been a paid consultant for Omeros, and the results should be interpreted in this context. Discussion Overall this is a strong study sup- porting the efficacy of phenyleph- rine 1.0%-ketorolac 0.3% for reduc- ing signs of IFIS in patients with a history of tamsulosin use. The study was adequately powered, and the authors demonstrated a significant reduction in intraoperative miosis and iris prolapse with Omidria. Strengths of the study also include I ntraoperative floppy iris syn- drome (IFIS), classically asso- ciated with alpha-1 adrenergic receptor antagonists such as tamsulosin, was first described by Chang and Campbell in 2005. 1 IFIS is characterized by a triad of iris billowing, iris prolapse, and progres- sive intraoperative miosis, and has been shown to increase the risk of surgical complications, underscoring the importance of identifying safe and effective management strate- gies. 2 Numerous interventions for the prevention and treatment of IFIS have been proposed including topical mydriatics and intracam- eral injections, modified incision construction and fluidic parameters, as well as iris hooks and Malyugin rings. Study summary Recently, phenylephrine 1.0%-ke- torolac 0.3% (Omidria, Omeros, Se- attle) was FDA-approved for intraop- erative mydriasis in cataract surgery as well as postoperative pain. 3 In the September issue of the Journal of Cat- aract & Refractive Surgery, Silverstein et al. evaluate the effect of Omidria on iris behavior in patients at risk for tamsulosin-associated IFIS. 4 This is the first study to examine Omidria specifically for the prevention of IFIS, and the authors highlight its potential advantages in this context, namely its ease of use as an additive to irrigating solution, and its FDA approval. In this single-surgeon, prospective trial, 50 eyes of 50 men with a history of tamsulosin use were randomized in a 1:1 fashion to treatment and control groups. Both groups received preoperative topical 1.0% tropicamide and 2.5% phenyl- ephrine for dilation. In the treat- ment group, 4.0 mL phenylephrine 1.0%-ketorolac 0.3% were added to the 500 mL irrigating solution prior to the start of cataract surgery. To be eligible for randomization, men had to have a history of prior or ongoing tamsulosin use and an indication for phacoemulsification without an additional, concomitant ophthalmic procedure. Exclusion criteria includ- ed diabetes, a previous ophthalmic diagnosis such as glaucoma or iris tears, a history of ocular trauma, current use of any ophthalmic medi- cation other than artificial tears, and current use of any systemic medica - tion known to affect pupil diame- ter, such as an opioid. Presence or absence of pseudoexfoliation and duration of tamsulosin use were not recorded. The primary endpoints of the study included change in pupil diameter before and after cataract extraction and change in pupil diameter prior to cataract extraction and after intraocular lens implanta- tion. Pupil diameter was measured from surgical videos using ImageJ software with a ruler reference. Ad- ditional primary endpoints were the rate of iris prolapse and iris billow- ing severity based on a novel, pro- posed iris billowing grading system. This new grading system assigns scores to the duration, frequency, and magnitude of iris billowing based on intraoperative video recordings taken from an endocy- clophotocoagulation (ECP) probe. The study was double-masked in the sense that the patient and surgeon were masked to the study groups. However, it is not clear whether or not reviewers of the surgical videos from which the data were collected were blinded to the treatment. All parametric data were analyzed using student t-tests, and nonparametric data were analyzed with a chi- squared test. After randomization, treatment and control groups had no statistical difference with respect to age, race or ethnicity, iris color, or cataract se- verity. In the Omidria group, mean pupillary diameter was significantly greater at all time points compared to the control group. Intraoperative pupillary constriction before and after cataract extraction averaged 0.38 ± 0.45 mm in the Omidria group compared to 1.23 ± 0.64 mm in controls (p<0.1). Mean pupillary constriction before cataract ex- Review of "Effect of phenylephrine 1.0% tamsulosin-associated intraoperative University of Pittsburgh Medical Center (UPMC) Eye Center residents; back row, from left: Tigran Kostanyan, MD, Leonid Zlotcavitch, MD, Jennifer Lee, MD, Kenny Taubenslag, MD; front row, from left: Siwei Zhou, MD, Anagha Medsinge, MD Ian Conner, MD, associate residency program director, UPMC Eye Center, University of Pittsburgh School of Medicine Evan Waxman, MD, residency program director, UPMC Eye Center, University of Pittsburgh School of Medicine IFIS continues to vex cataract surgeons. This month, I invited the Pittsburgh residents to review a study on phenylephrine that appears in the September issue of JCRS. —David F. Chang, MD, EyeWorld journal club editor

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