Eyeworld

EW RESIDENTS 108 October 2015 enced a rise in intraocular pressure, with occurrence rates of 3.5% in the placebo group and 4.7% in the OMS302 group. While the pressure increases compared to baseline were less notable at postoperative day 2, several subjects did have an abnor- mally elevated intraocular pressure through the end of the study period in both groups. Analysis This well-designed study addresses two vital aspects of cataract surgery —pupillary dilation and postop- erative pain. Pupillary dilation is important because intraoperative miosis can obstruct the surgeon's view and lead to complications with undesirable surgical outcomes. Also, in this day and age, patients expect to be largely free from discomfort and pain following cataract surgery. The large sample size in this study is a definite strength, as it is even greater than the calculated number of patients needed to reach statistically significant outcomes. Randomization resulted in treat- ment and control groups that were equal at baseline with regard to age, sex, race, pupil color, and cataract grade, negating these potentially confounding variables. The strict ex- clusion criteria created high internal validity, ensuring the results seen were due to treatment effect alone. Additionally, the method of admin- istering the study drug lent itself well to masking patients, surgeons, and observers; adding a clear solu- tion of OMS302 into the balanced salt solution bottle was easily done preoperatively without changing surgical steps or the appearance of the balanced salt solution in any way. Many data points were col- lected for each primary endpoint, strengthening the results that favored the treatment group. The pupil size actually increased intraoperatively with OMS302 compared to decreasing 0.5 mm in the control group, and metic- ulous patient surveys proved that postoperative pain was decreased in the treatment group. In addition to proving the efficacy of the treat- ment, the safety of the medication was also studied, and no adverse events directly attributable to OMS302 were found. While this study was well designed, we did note a few weak- nesses and areas that should be addressed in future investigations. Review continued from page 107 Carol L. Shields, MD, Co-Chief, Oncology Jerry A. Shields, MD, Co-Chief, Oncology Celebrating 40 Years Fighting for Life and Sight. 840 Walnut Street, Philadelphia, PA 19107 www.willseye.org The Ocular Oncology Service at Wills Eye Hospital is the preeminent center for the diagnosis and treatment of eye tumors and cancers. Many of the treatments used today worldwide to cure eye cancer were developed at Wills Eye. From infants with retinoblastoma to adults with intraocular melanoma and lymphoma, saving lives and sight has b een the mission for 40 years. Congratulations to an amazing team of physicians and staff. Ranked one of the top eye hospitals in the nation every year. EyeWorld-Shields-9-16_Oct Issue 9/16/15 5:18 PM Page 1 receiving placebo (27.1%). With the use of OMS302, pupil diameter at the time of completion of cortical cleanup was >6 mm in 96.0% of eyes, whereas only 77.0% of patients receiving placebo maintained a pu- pil diameter of >6 mm at this time. Using the 100-mm VAS (Visual Analog Scale) for evaluating ocular pain, patients who received OMS302 were noted to have a 4.89-mm lower pain score compared to placebo during the first 12 hours follow- ing surgery, which was statistically significant. The authors also report- ed that 25.8% of patients receiving OMS302 were pain-free at all times compared to only 17.1% of patients in the placebo group. The need for analgesics on the day of surgery was significantly less in the OMS302 group (24.6%) than for patients in the placebo group (35.1%). Adverse events occurred in similar proportions for patients in the placebo group and the OMS302 group (66.9% and 60.0%, respec- tively). The most common adverse events reported were eye pain, eye inflammation, anterior chamber inflammation, and headache. Of note, patients in both groups experi-

• Cover