Comparison of DEXTENZA Insert Versus Topical Steroid Drops for Managing Pain and Inflammation After Vitreoretinal Surgery

What this Trial Is About

This clinical trial evaluates pain and inflammation control after vitreoretinal surgery, focusing on patients aged 18 and older undergoing pars plana vitrectomy for macular hole, epiretinal membrane removal, or vitreomacular traction. The study compares two treatments a corticosteroid insert and topical steroid eye drops, aiming to improve postoperative management. The rationale is that topical steroids rely on patient adherence and may vary in effectiveness, while the insert provides continuous drug delivery over 30 days. Participants are randomly assigned to one of two groups. One group receives the DEXTENZA4 intracanalicular dexamethasone insert placed via the lower eyelid canaliculus immediately after surgery, which releases medication automatically for up to 30 days. The other group uses prednisolone acetate 1% eye drops, applied four times daily for the first week after surgery. Both groups also receive standard topical antibiotic treatment. The study is conducted in a parallel design with single masking. During the study, participants are monitored at days 1, 3, 7, 14, and 21 after surgery. Researchers assess inflammation control, pain levels using a visual analog scale, inflammation by anterior segment OCT, visual acuity changes, rebound inflammation, rescue treatment use, and any adverse events. Postoperative communication may include telephone or electronic messaging. The primary outcome is inflammation control at day 14, with follow-up continuing through day 21. Total participation lasts about three weeks after surgery.

Dextenza in the Post-op Management of Vitreoretinal Surgeries