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Phenylephrine 1%/ketorolac injection 0.3% added to ophthalmic irrigation solution and administered intracamerally during cataract surgery was associated with a statistically significant reduction in surgical time, intraoperative complications, and use of pupil dilating devices and with a statistically significant improvement in best-corrected visual acuity.
Take-Home Message: Phenylephrine 1%/ketorolac injection 0.3% added to ophthalmic irrigation solution and administered intracamerally during cataract surgery was associated with a statistically significant reduction in surgical time, intraoperative complications, and use of pupil dilating devices and with a statistically significant improvement in best-corrected visual acuity.
By Lynda Charters; Reviewed by Eric D. Donnenfeld, MD
Efforts to improve the performance and outcomes of cataract surgery continue, and surgeons have taken another step forward in that regard.
The addition of intracameral phenylephrine/ketorolac to the surgical regimen is known to maintain pupillary dilation.
In addition, investigators also found the drug combination of phenylephrine 1.0% and ketorolac 0.3% (Omidria, Omeros Corp.) was superior to intracameral epinephrine by decreasing the rates of intraocular complications, the necessity for using pupillary dilation devices during cataract surgery, the length of the surgery, and best-corrected visual acuity (BCVA) outcomes.
The agent is the first combination drug administered intracamerally to receive FDA approval for routine use during cataract surgery.
Because cataract surgery is one of the most frequently performed procedures worldwide and the technology associated with the surgery is so far advanced, patients have increasingly high expectations for a safe, rapid, and comfortable return of functional vision, noted Eric D. Donnenfeld, MD.
However, despite the frequency with which cataract surgeries are performed, complications related to the surgery can still occur, with small pupils being a well-known risk factor for complications, said Dr. Donnenfeld, clinical professor of ophthalmology, New York University School of Medicine, New York, and founding partner, Ophthalmic Consultants of Long Island and Connecticut.
Visualization is all-important during creation of the capsulorhexis, phacoemulsification, cortical clean-up, and IOL implantation. In patients with small pupils, the surgical scenes can differ dramatically between well-dilated pupils and miotic pupils.
When the intracameral combination of phenylephrine and ketorolac was being evaluated, the FDA trials showed significant improvements in the drug’s ability to maintain pupillary mydriasis and reductions in postoperative pain. All trial patients received preoperative topical mydriatics and analgesics, no preoperative nonsteroidal anti-inflammatory drugs (NSAIDs) or intracameral epinephrine were administered in the experimental and control groups. Patients with risk factors for pupillary constriction, such as intraoperative floppy iris syndrome (IFIS) and pseudoexfoliation, were excluded from the FDA trials.
NEXT: Video with Robert H. Osher, MD
Robert H. Osher, MD, explains how he has found that use of phenylephrine/ketorolac 1%/0.3% makes cataract surgery safer. (Video courtesy of Robert H. Osher, MD)
Dr. Donnenfeld and colleagues conducted a retrospective chart analysis to test the efficacy of the intracameral drug combination for its effects on perioperative complications, surgical duration, changes in BCVA and uncorrected visual acuity (UCVA) levels, and the use of devices to dilate pupils in a patient population.
This study was more encompassing than that in the FDA trials and included patients with IFIS, pseudoexfoliation, and otherwise poorly dilating pupils.
Four surgeons performed all procedures at one study site from August to November 2015, he explained.
The drug combination was added to the balanced saline irrigating solution in the study group, and epinephrine was added to the irrigating solution in the control group.
Investigators compared the results from both groups. Patients in both groups received standard topical NSAIDs administered preoperatively. All charts were reviewed at least 1 month postoperatively. Patients were excluded who had a sensitivity to NSAIDs and had undergone combined cataract and posterior segment surgeries.
Dr. Donnenfeld reported that 641 cataract extractions were performed in 389 patients (413 women, 228 men). Two hundred sixty patients received the intracameral phenylephrine 1.0% and ketorolac 0.3% drug combination and 381 received intracameral epinephrine. Forty-five patients required use of a Malyugin ring or iris hooks.
The surgical duration was significantly (p = 0.049) shorter in the group treated with the drug combination when all patients were included in the analysis. The greatest difference was seen in patients who ranged in age from 65 to 70 years, i.e., in the drug combination group, the surgery lasted 13.5 minutes compared with 17.2 minutes in the epinephrine group.
Twenty adverse events occurred for a rate of 3.1% that included a dislocated lens with IOL exchange or repositioning, retained and dropped lens fragments, wound leakage, capsular tear alone, capsular tear and anterior vitrectomy, macular puckering postoperatively, and retinal detachment postoperatively.
“A higher incidence of complications was seen when pupillary dilating devices were used (11.1% with rings and hooks versus 2.5% with no devices, p = 0.001), and a lower incidence of complications occurred in the drug combination group compared with the epinephrine group (1.1% versus 4.5%, respectively, p = 0.018),” he said.
When the complications data were analyzed for all patients, Dr. Donnenfeld reported, “Complications occurred most frequently when both mydriatic-assist devices were used in conjunction without the drug combination; conversely, complications occurred least frequently when the drug combination was administered concurrently without a mydriatic-assist device.”
In the 53 patients who had a history of use of alpha-1 adrenergic antagonists, the use of the drug combination was associated with a lower dependence on mydriatic assist devices.
There was a significant improvement in the mean BCVA day 1 postoperatively in the age-matched patients who received the drug combination compared with those who received epinephrine. For patients aged 69 to 76 years, the respective BCVA was 0.44 ± 0.08 versus 0.38 ± 0.10, and for those aged 76 to 92 years, the respective BCVA was 0.34 ± 0.06 versus 0.23 ± 0.08 (p < 0.001).
In the age-matched patients, a significant improvement was seen in UCVA on day 1 postoperatively in patients who received the drug combination.
The differences between the two study groups increased with increasing patient age, such that in those 62 to 68 years, the respective visual acuities in the drug combination group and epinephrine group were 0.428 and 0.395, in those 69 to 75 years, 0.443 and 0.383, and in those 76 to 92 years 0.339 and 0.227 (p = 0.003).
Dr. Donnenfeld summarized, “When compared to intracameral epinephrine, intracameral phenylephrine/ketorolac administration was associated with statistically significant decreases in intraoperative and postoperative complications, decreased use of pupillary dilating devices, improved UCVA on day 1 postoperatively, and decreased surgical time.”
Eric D. Donnenfeld, MD
Dr. Donnenfeld is a consultant to Omeros Corp. The study was completed and reported independently from Omeros.