Omidria maintains mydriasis during pediatric cataract surgery
In addition, postoperative pain levels were reduced compared with using phenylephrine alone.
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There are benefits to using Omidria during pediatric cataract surgery, including in infants, according to a study.
“Based on the findings from this study, Omidria is the only FDA-approved product for pediatric use as an agent to prevent intraoperative miosis and prevent postoperative pain,” study co-author M. Edward Wilson, MD, told Ocular Surgery News.
Wilson and colleagues assessed the safety of Omidria (phenylephrine 1% and ketorolac 0.3% intraocular solution, Omeros) compared with phenylephrine in children aged 0 to 3 years who were undergoing cataract surgery. The researchers also assessed the effect on postoperative pain and intraoperative pupil diameter.
The multicenter, randomized, double-masked phase 3 clinical trial included 78 patients who received intervention. Depending on randomization, patients received 4 mL of Omidria or phenylephrine 1% in the surgical irrigation solution. Safety endpoints were assessed up to 90 days postoperatively.
Thirty-seven eyes underwent primary IOL implantation, with 18 receiving Omidria and 19 receiving phenylephrine. Forty-one eyes were left aphakic at the time of cataract surgery, with 19 receiving Omidria and 22 receiving phenylephrine. Six patients were not included in the final analysis because four patients in the Omidria group and two patients in the phenylephrine group were ineligible to receive the assigned intervention.
Well-tolerated therapy
The final cohort included 32 patients who received Omidria and 40 patients who received phenylephrine. Overall, Omidria was well tolerated, and there was no significant difference in the safety profile of Omidria compared with phenylephrine alone, Wilson said.
“There is no commercially available phenylephrine for intraocular use. Plus, the addition of ketorolac (based on adult studies) helps to control pain and pupil size when compared to phenylephrine alone. In our pediatric study, pain was less with Omidria than with phenylephrine alone, but we were not powered to assess pain since it was an FDA-directed safety study,” Wilson, an OSN Pediatrics/Strabismus Board Member, said.
The difference in pupil diameter from baseline to final follow-up was not significantly different between the two groups. The mean pupil diameter at baseline in the Omidria cohort was 6.97 mm compared with 7.06 mm at final follow-up. The mean pupil diameter in the phenylephrine-alone cohort was 7.21 mm compared with 7.3 mm at final follow-up.
Postoperative pain
Additionally, the time-weighted average pain scores 24 hours postoperatively, estimated by area under the curve, were similar between the two cohorts. The area under the curve pain scores were lower in the Omidria cohort compared with phenylephrine alone, but the difference was not statistically significant.
However, at 6 hours and 24 hours postoperatively, Omidria provided statistically significant reductions in pain compared with just phenylephrine.
“While non-preserved epinephrine in the irrigation fluid at surgery has been the standard for pediatric cataract surgery, we now have an FDA-approved product that provides the needed intraoperative pupil size stability of epinephrine but also adds postoperative pain control,” Wilson said.
Omidria is an “ideal product for pediatric cataract surgery” and will improve safety and reduce complications, Wilson said.
- For more information:
- M. Edward Wilson, MD, can be reached at Albert Florens Storm Eye Institute, 167 Ashley Ave., Charleston, SC 29425; email: wilsonme@musc.edu.
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