Study Comparing Dextenza Eye Insert Versus Standard Steroid Drops After Refractive Lens Exchange Surgery for Post-Operative Inflammation

What this Trial Is About

Researchers are evaluating the outcomes of patients undergoing bilateral refractive lens exchange RLE surgery by comparing two treatments for post-operative inflammation a dexamethasone ophthalmic insert called Dextenza and a standard topical steroid drop, prednisolone acetate. The study focuses on patient preference between the insert and drops, as well as clinical outcomes including inflammation and the risk of cystoid macular edema after surgery. This is a randomized, controlled, prospective study designed to assess effectiveness and safety. In this study, one eye of each participant receives the Dextenza insert, which provides a sustained delivery of dexamethasone over 30 days with a single placement in the canaliculus. The other eye receives prednisolone acetate eye drops following a tapering schedule starting with four times daily for one week, then three times daily for one week, twice daily for one week, and once daily for a final week. All eyes also receive topical moxifloxacin four times daily for one week and topical Ilevro once daily for four weeks as part of standard post-operative care. Participants will have post-operative evaluations on Day 1, Day 7, and one month after surgery. Researchers will monitor patient preference, inflammation levels, pain scores, incidence and grade of corneal haze, anterior chamber cell count, and visual acuity measures during this period. The total participation time is approximately one month, during which safety and effectiveness outcomes related to the treatments will be collected and analyzed.

The PRIME Study: A Randomized, Controlled, Prospective Study