Reviewed by Denise M. Visco, MD, MBA and Keith A. Walter, MD
Use of the drug combination of an anti-inflammatory agent and a mydriatic, i.e., ketorolac and phenylephrine (Omidria, Omeros Corp.), administered intracamerally effectively reduced cystoid macular edema (CME) after cataract surgery when compared wth the use of combined therapy comprised of a topical steroid and nonsteroidal anti-inflammatory agent (NSAID).
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Two recent studies have reported the benefits of the combination.
In the first study, Denise Visco, MD, MBA, who is in private practice at Eyes of York Cataract and Laser Center, York, PA, and colleagues retrospectively analyzed the charts of 2,277 patients who underwent cataract surgery. The patients were divided into two treatment groups for the research.
The first group (1,382 patients) received intracameral phenylephrine/ketorolac 1%/0.3% intraoperatively and topical NSAIDs bromfenac ophthalmic solution (BromSite, Sun Pharmaceuticals) two days preoperatively and 10 weeks postoperatively.
The second group (895 patients) received only topical NSAIDs and topical steroids loteprednol etabonate ophthalmic suspension (Lotemax, Bausch + Lomb) and bromfenac ophthalmic solution (Prolensa, Bausch + Lomb) for the same preoperative and postoperative periods.
Previous surgical experience with phenylephrine/ketorolac 1%/0.3% has shown that the drug maintains iris tone during cataract surgery, prevents intraoperative floppy iris syndrome, maintains pupil dilation better than epinephrine, and decreases surgical complications, including the need for pupil expansion devices, and cataract surgical times, Dr. Visco explained.
Dr. Visco also pointed out that miosis can be problematic for patients undergoing cataract surgery because the iris sphincter muscle is stimulated by prostaglandins released with surgical trauma, which causes miosis.
There are a number of risk factors for miosis. While mechanical methods are intended to decrease the risk of miosis, they also can damage the iris and result in more release of prostaglandins.
Other risk factors include ocular comorbidities and previous ocular trauma.
Dr. Visco recounted a recent study in which 25% of patients without any risk factors for miosis developed it intraoperatively. If miosis does develop, there is reportedly an increased likelihood of complications, in addition to increased surgical risk, cost, and prolonged surgical time.
The results of the study showed that the first group in which intracameral phenylephrine/ketorolac 1%/0.3% and no steroid fared better than the second group that received only topical steroids and NSAIDs.
The respective incidence rates of postoperative CME in patients without preoperative vitreomacular traction were 0.217% compared with 0.603%; those of rebound iritis, 1.95% compared with 4.32%; and those of postoperative pain and photophobia, 1.74% compared with 5.83%. “These results provide a higher quality patient experience,” the investigators noted.
“We know from post-market studies that Omidria can improve the surgeons’ experience in the operating room and help them deliver a great outcome,” Dr. Visco said. “We now have evidence That we are also providing a better experience for our patients by reducing the rate of postoperative complications including rebound iritis, pain, photophobia, and CME after cataract surgery.”
In the second study, carried out by Keith Walter, MD, and colleagues Levi Kauffman, MD, and Justin Hess, MS, the team retrospectively reviewed the charts of patients who underwent cataract surgery for whom intraoperative (Omidria) and postoperative NSAIDs were used without topical steroids.
The goal of the research study was to determine the incidence of pseudophakic CME with this treatment regimen.
Dr. Walter is a professor of ophthalmology, Wake Forest School of Medicine, Winston-Salem, NC. The same surgeon performed all surgeries from Jan. 1, 2016, through Dec. 31, 2017.
The following data were collected from the medical records of the patients: the intraoperative and postoperative medication regimen, visual outcome, and development of postoperative CME. Patients with a history of uveitis, diabetic macular edema, retinal vein occlusions, epiretinal membranes, vitreomacular traction or a history of macular edema are excluded from the study.
A total of 505 eyes were included in the analysis. Of those, CME developed in two patients for an incidence of 0.39%.
“This rate is below historical comparisons by five- to 10-fold for the rate of CME development with the use of topical steroids,” Dr. Walter pointed out.
There are some benefits that could lead to better outcomes for patients, and Dr. Walter noted that controlling CME seems to be one factor.
“Using Omidria appears to control postoperative CME so that you can eliminate the topical steroid, making the drop burden less for the patient, while reducing unscheduled postoperative
patient visits and complications,” he concluded.
Denise Visco, MD, MBA
E: [email protected]
Dr. Visco is a consultant to Omeros Corp.
Keith Walter, MD
E: [email protected]
Dr. Walter is a consultant to Omeros Corp.