Eyeworld

tient compliance and ability to administer drops, may not be 100% applicable to this study. In regard to statistical analysis, the authors provide a number of comparisons they made for multiple endpoints (VA, inflammation, IOP, and corneal edema). All of those were also test- ed at multiple time points. BCVA was analyzed in a logMAR format, IOP was converted to a binary covariate if >24 or not, and inflam- mation and corneal edema were graded on a 4-point ordinal scale. An odds ratio was deter- mined using ordinal (logistic) regression, and in some circumstances they adjusted for potential confounding variables, therefore some models were multivariate. Of note, there is lack of accounting for multiplicity; with the repeated testing at differ- ent time points, the p values should be adjusted to control for the type 1 error. The authors did perform a repeated measures ANOVA on some of the repeated VA analyses, but there was no adjustment of p values for the multiple looks at the odds ratios and p values in Table 2 of the study. If a simple Bonferroni correction was ap- plied to that table, for each row, some of those findings would no longer be significant. While the promise of dropless cataract sur- gery has been demonstrated in the literature, to date it has not been widely adopted in the U.S. At the top of the list of concerns are those sur- rounding the compounding process, which are subject to human error, such as dilution error injectable steroid following cataract surgery. A 2013 meta-analysis found that 32% of patients develop ocular hypertension following 4.0 mg of triamcinolone 5 . However, this study showed no statistical significant difference between the two groups at final follow-up with regard to IOP. The evidence presented here may help to alleviate concerns surrounding high IOP in a dropless approach involving steroid injection. Ultimately, the study set out to compare the effectiveness of Tri-Moxi to standard eye drop regimen in controlling postoperative inflam- mation, corneal edema, and elevation in IOP. Through its large sample size and similar study groups, the authors successfully demonstrate non-inferiority of Tri-Moxi compared to stan- dard postoperative drug regimens in reducing the degree of intraocular inflammation and corneal edema, without a difference noted in elevated IOP between the two groups. The authors self-disclose many of the study weaknesses. From a study design perspective, the initial decision of whether a patient received dropless versus standardized therapy was left to discretion of the surgeon. The authors note that the surgeons did take into account patient preferences and almost undeniably patient reli- ability, introducing an element of selection bias, potentially influencing the ultimate results. The authors also note the limitations of a 1-month follow-up period, particularly related to the fact that one of the most common post- operative complications of pseudophakic CME classically presents after the 1-month period. The authors note that the specific NSAID used was non-standard due to issues surround- ing insurance. While this is unlikely to have affected outcomes in a significant manner, it is rightfully noted. Also, the authors are ideally seeking to evaluate the effectiveness of drop- less cataract surgery's impact on postoperative inflammation, but both groups still required use of a topical NSAID. As this does not represent truly dropless cataract surgery, some of the strengths noted above, particularly around pa- intravitreal triamcinolone acetonide/ peri-operative eye drops in cataract Case Western Reserve University residents, from left: Rahul Raghu, MD, Patrick Pham, MD, Samuel Dresner, MD, Huy Ly, MD, Ashraf Ahmad, MD JUNE 2019 | EYEWORLD | 19 continued on page 20 Although "dropless"surgery is an appealing concept, intravitreal injection of a compounded triamcino- lone-moxifloxacin formu- lation has never undergone an FDA clinical trial. I've asked the Case Western residents to review this head-to-head comparison with topical therapy that ap- pears in this month's JCRS. —David F. Chang, MD, EyeWorld Journal Club editor

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