Intracameral phenylephrine and ketorolac injection (OMS302) for maintenance of intraoperative pupil diameter and reduction of postoperative pain in intraocular lens replacement with phacoemulsification

Abstract

BackgroundThe purpose of this study was to evaluate the effect of OMS302 on intraoperative pupil diameter and early postoperative ocular pain when administered during intraocular lens replacement surgery.MethodsFour hundred and six patients (406 study eyes; 202 in the OMS302 group and 204 in the placebo group) were entered into this randomized, double-masked, placebo-controlled, multicenter Phase III study, which was conducted at 15 centers in the USA and the Netherlands. The patients received OMS302 (60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine) or placebo in irrigation solution during intraocular lens replacement. No other changes in procedure were required. Coprimary endpoints were change in pupil diameter over time from surgical baseline to end of procedure and patient-reported ocular pain during the first 12 hours postoperatively. Secondary endpoints included additional measures of pupil diameter and postoperative pain.ResultsOMS302 was superior to placebo in maintaining intraoperative mydriasis, preventing miosis, and reducing postoperative pain. The weighted mean (standard error) difference (OMS302 – placebo) in change in the area under the curve from baseline for pupil diameter was 0.590 ([0.049]; 95% confidence interval 0.494 to 0.686; P<0.0001). For ocular pain scores, the weighted mean (standard error) difference was −4.580 ([1.192]; 95% confidence interval −6.917 to 2.244; P=0.0002). All secondary efficacy results favored OMS302. Specifically, analyses supporting prevention of miosis (patients with ≥6 mm pupil diameter at completion of cortical clean-up and those with <6 mm diameter at any time during surgery) were significant for OMS302 (95.9% versus 77.0% and 9.2% versus 38.0%, respectively; P<0.0001 for each endpoint). OMS302 was well tolerated and not associated with any unexpected adverse events.ConclusionOMS302 maintained mydriasis, prevented miosis, and reduced early postoperative pain when administered in irrigation solution during intraocular lens replacement, with a safety profile similar to that of placebo. OMS302 is preservative-free and bisulfite-free, and its administration does not require any modification to the surgical procedure.

Management of mydriasis and pain in cataract and intraocular lens surgery: review of current medications and future directions

“…In November of 2013, the combined results of the two Phase III clinical trials (both including >400 participants) were presented as a scientific poster at the American Academy of Ophthalmology Annual Meeting in New Orleans 91. The results showed that OMS302 maintained a necessary pupil diameter throughout the IOL replacement procedure, while the placebo group showed progressive constriction ( P <0.00001).…”

Comparison of the frequency of use of a pupil expansion device with and without an intracameral phenylephrine and ketorolac injection 1%/0.3% at the time of routine cataract surgery

“…Intraoperative miosis can affect visualization of the surgical field; increase the risk of complications, inflammation, and postoperative pain; and reduce patient satisfaction 1. Failure to maintain an adequate pupil diameter can increase the difficulty of the procedure and increase the risk of intraoperative and postoperative complications 2. Intraoperative pupil constriction can make every step of a cataract procedure more challenging and problematic by limiting the size of the capsulorhexis, increasing the risk of iris injury, and reducing visualization for phacoemulsification and lens implantation 3.…”

“…Maintenance of mydriasis throughout surgery to allow for better visualization of the surgical field and a greater working area within the pupil is crucial for successful surgical outcomes 4. Postoperative pain is associated with clinical outcomes and patient well-being, preventing or reducing postoperative pain can improve patient satisfaction 1,2. Reduction of postoperative pain is important because patient expectations are high in modern cataract surgery and ocular pain, and discomfort represents a common cause of patient dissatisfaction 5…”

“…The initial effect achieved by topical mydriatics, however, may not be sustained throughout the procedure 2. Even with the use of topical mydriatic drops, intraoperative miosis due to the release of prostaglandins in response to surgical trauma may still occur 6.…”

“…Topical and intracameral NSAIDs can contribute to the maintenance of dilation by blocking the miotic effects of prostaglandins released during cataract surgery. However, topical drugs and their effects can be washed out of the anterior chamber by irrigating solutions 2,7…”