A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement

Summary

The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when administered in irrigation solution during cataract extraction on intraoperative pupil diameter, acute postoperative pain, and safety in children birth through 3 years.

Timeline

Start

2014-07

Primary completion

2016-09-12

Completion

2016-09-12

Publications

• Background Wilson ME, Trivedi RH, Plager DA. Safety and efficacy data supporting U.S. FDA approval of intracameral phenylephrine and ketorolac 1.0%/0.3% for pediatric cataract surgery: clinical safety and pupil and pain management. J Cataract Refract Surg. 2020 Jun;46(6):873-878. doi: 10.1097/j.jcrs.0000000000000194.

Drugs

Indications