Reply

Sullivan-Mackenna et  al. criticize the retrospective design of our study and reject the notion that performing a randomized trial in this instance would be unethical. We performed a retrospective analysis because we did not realize the significant benefits of Omidria until we were using it in every case. After more th an 100 cases in which Omidria was used, we reviewed our data to verify our impression that the drug was indeed providing a benefit. Observing for ourselves the consistent mydriatic-sustaining benefit as well as the substantial pain control of Omidria together with our review of the data from the con trolled clinical trials performed for regulatory approval, including a trial showing clear superiority over the active comparator phenylephrine, we believe it would have been unethical to randomize FLACS patients to a “no-treatment” arm in which the case would take longer and increase the risk f or iris damage.
Source: Journal of Cataract and Refractive Surgery - Category: Opthalmology Authors: Tags: Letter Source Type: research