Abstract
Purpose :
To compare intraoperative mydriasis during phacoemulsification cataract surgery associated with use of intracameral phenylephrine 1.0%/ketorolac 0.3% (Omidria®) versus intracameral epinephrine. There are currently two published prospective randomized controlled trials comparing Omidria® to placebo, phenylephrine alone, and ketorolac alone. Both of these studies report that Omidria® is superior to placebo for the maintenance of mydriasis during cataract surgery. However, there are no studies comparing Omidria® to epinephrine, which has been used by ophthalmologists for years to facilitate intraoperative mydriasis during cataract surgery.
Methods :
Prospective, randomized single-masked study of patients who underwent bilateral, sequential phacoemulsification cataract surgery by a single surgeon at an academic medical center. The first eye was randomly assigned to receive Omidria® or epinephrine and the fellow eye was assigned to the other mydriatic agent. Videos of each surgery were reviewed by a single masked examiner, who measured pupil diameter from the time of incision (baseline) until wound closure at 1-minute intervals. The primary endpoint is the mean area under the curve (AUC) change from baseline in pupil diameter over time to the end of cataract surgery. Secondary endpoints include maximum intraoperative pupil constriction compared to baseline, proportion of eyes with pupil diameter less than 6.5 mm at any time during surgery, proportion of eyes with pupil diameter less than 6.0 mm during cortical clean-up, and proportion of eyes with greater than 2.5 mm of pupillary constriction at any time during surgery.
Results :
Sixteen eyes from eight patients have been enrolled in the study to date. At the current average enrollment rate of two eyes per week, we anticipate having results from at least fifty eyes of twenty-five patients by end of April 2017. The mean AUC change from baseline was 0.45 mm in the Omidria® group and 0.36 mm in the epinephrine group.
Conclusions :
Based on the data collected to date, there is no statistically significant difference between intracameral Omidria® and intracameral epinephrine with respect to maintenance of mydriasis during phacoemulsification cataract surgery. Additional data are being collected and will be reported.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.