Eyeworld

107 EW RESIDENTS October 2018 the discussion. For example, topical atropine with or without or intraca- meral epinephrine has been shown to be efficacious in several small series. 7,8 With a number of available options for managing IFIS, a more interesting study would have com- pared Omidria to a stronger control group. Even the addition of a topical preoperative NSAID, which is stan- dard practice for many surgeons, to both treatment and control arms would have made a more compel- ling case for intracameral phenyl- ephrine-ketorolac. A head-to-head comparison comparing Omidria to the only other FDA-approved addition to irrigating solution for intraoperative mydriasis, adrenaline, would also be a welcome addition to the literature. Though this study does support the efficacy of Omidria in the prevention of tamsulosin-as- sociated IFIS, it brings us no closer to determining the optimal manage- ment for this increasingly common phenomenon, which is all the more problematic when considering the cost of Omidria. Until December 31, 2017, Omidria cost approximately $465.00 per single-patient use vial and had pass-through payment status from CMS. However, pass-through status has since expired. Omeros offers a facility reimbursement for the dif- ference between cost and insurance coverage as well as a patient assis- tance program for patients without insurance or with government insurance; still, the cost and admin- istrative burden of enrolling patients may affect surgeon utilization. EW References 1. Chang DF, Campbell JR. Intraoperative flop- py iris syndrome associated with tamsulosin. J Cataract Refract Surg. 2005;31:664–73. 2. Haridas A, et al. Intraoperative floppy iris syndrome (IFIS) in patients receiving tamsu- losin or doxazosin—a UK-based comparison of incidence and complication rates. Graefes Arch Clin Exp Ophthalmol. 2013;251:1541–5. 3. Hovanesian JA, et al. Intracameral phenyl- ephrine and ketorolac during cataract surgery to maintain intraoperative mydriasis and reduce postoperative ocular pain: integrated results from 2 pivotal phase 3 studies. J Cata- its prospective and randomized design. The study was not adequate- ly powered to detect a difference in complication rates between treat- ment and control groups. In theory, as IFIS has been associated with increased rate of surgical compli- cations, use of Omidria in patients with a history of tamsulosin use should reduce the risk of iris trauma, retained cortex, and posterior capsu- lar rupture; however, a much larger study would be necessary to confirm or refute this hypothesis. 2 Addition- ally, as only patients on tamsulosin were studied, the results cannot be extrapolated to patients on other medications implicated in IFIS such as other alpha-blockers, antipsychot- ics, or saw palmetto. The study puts forth its novel iris billowing grading scale based on ECP probe recordings as an aid to future research on IFIS. Higher scores in the control group support the validity of the grading scale. However, the grading scale has not yet been shown to correlate with any other outcomes such as intra- operative miosis or surgical com- plications. Additionally, the study does not state how many reviewers scored the videos and therefore does not address intra- and inter-reader scoring variability. Additional work is necessary before such a grading system is adopted in the cataract community as a meaningful out- come metric. One weakness of the paper is the discussion's handling of alter- native approaches to pupil man- agement. For example, the authors characterize the Malyugin ring as "somewhat" effective in IFIS, while at least one prior study demonstrat- ed excellent efficacy in maintaining pupillary diameter. 5 The discussion claims that epi-Shugarcaine has been shown to make no difference in the reduction of IFIS. However, the single paper cited to make this claim is a retrospective series where the presence of IFIS was deduced from operative reports, raising concern for recall bias. 6 A number of other historical methods for managing IFIS are also omitted from ract Refract Surg. 2015;41:2060–8. 4. Silverstein SM, et al. Effect of phenyl- ephrine 1.0%-ketorolac 0.3% injection on tamsulosin-associated intraoperative floppy iris syndrome. J Cataract Refract Surg. 2018;44:1103–1108. 5. Chang DF. Use of Malyugin pupil expansion device for intraoperative floppy-iris syndrome: results in 30 consecutive cases. J Cataract Refract Surg. 2008;34:835–41. 6. Chen AA, et al. Pharmacologic prophylaxis and risk factors for intraoperative floppy-iris syndrome in phacoemulsification performed by resident physicians. J Cataract Refract Surg. 2010;36:898–905. 7. Bendel RE, Phillips MB. Preoperative use of atropine to prevent intraoperative floppy-iris syndrome in patients taking tamsulosin. J Cataract Refract Surg. 2006;32:1603–5. 8. Masket S, Belani S. Combined preoperative topical atropine sulfate 1% and intracameral nonpreserved epinephrine hydrochloride 1:4000 [corrected] for management of intraoperative floppy-iris syndrome. J Cataract Refract Surg. 2007;33:580–2. Contact information Connor: connerip@upmc.edu Waxman: waxmane@upmc.edu ketorolac 0.3% injection on floppy iris syndrome" Effect of phenylephrine 1.0%-ketorolac 0.3% injection on tamsulosin-associated intraoperative floppy iris syndrome Steven Silverstein, MD, Viren Rana, MS, Robert Stephens, PhD, Larry Segars, PharmD, Joseph Pankratz, MS, Shivani Rana, Mark Juzych, MD, Nissiri Nariman, MD J Cataract Refract Surg. 2018;44(9):1103–1108. Purpose: To determine the effect of Omidria (phenylephrine and ketorolac injection 1%/0.3%) on different components of intraoperative floppy iris syndrome (IFIS). Setting: Silverstein Eye Centers, Kansas City, Missouri Design: A single surgeon, single center, double-masked prospective comparative study double Methods: 50 eyes of 50 male patients treated with tamsulosin underwent standard cataract extraction surgery. Twenty-five patients (the treatment group) received phenylephrine and ketorolac injection 1%/0.3% in the irrigation solution, while 25 patients (the control group) received basic saline solution. Every procedure was video recorded using endoscopic cyclophotocoagulation (ECP) probe and microscopic view. Pupil dilation, iris billowing, and iris prolapse were measured using a micrometer, ECP recording grading scale, and microscopic recordings, respectively. Results: While both groups showed a decrease in pupillary diameter before and after cataract extraction, and before cataract extraction and after intraocular lens implant, the changes were statistically significantly greater in the treatment group. Iris prolapse occurred in 3 out of 25 (12.0%) in the treatment group versus 14 out of 25 (56.0%) in the control (p<0.001). Stage 3 (severe) billowing was seen in 1 (4.0%) of the treatment group and 10 (40.0%) of the control (p<0.001). Conclusions: The use of the phenylephrine and ketorolac injection 1%/0.3% combination added to the irrigating solution during cataract surgery in patients at risk for IFIS leads to significantly better prevention of miosis, less pupillary billowing, and a reduced incidence of iris prolapse. A new grading scale for intraoperative iris abnormalities may be used for future evaluation.

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