Evaluating a Sustained-Release Dexamethasone Insert as Adjunctive Therapy for Inflammation and Pain Post-Corneal Transplantation
Abstract
Purpose: To assess the efficiency and safety of an intracanalicular dexamethasone insert (Dextenza, Ocular Therapeutix, Inc) supplemented with a reduced-frequency topical drop regimen in mitigating pain and inflammation post-penetrating keratoplasty (PKP), Descemet stripping endothelial keratoplasty (DSEK), and Descemet membrane endothelial keratoplasty (DMEK), compared to standard topical corticosteroid therapy.
Patients and methods: Eyes were categorized within the DSEK, DMEK, or PKP groups based on ocular characteristics and surgical indications. Randomized in a 1:1 ratio, the intervention group received Dextenza alongside a lowered drop frequency, while the control group followed a conventional drop protocol with no Dextenza. Primary outcomes included average pain scores and absence of anterior chamber cell and flare. Secondary outcomes included delayed re-epithelialization, corneal rejection episodes, instances of intraocular pressure (IOP) elevation >10mmHg above baseline, cystoid macular edema (CME) occurrence, and the necessity for steroid rescue.
Results: The study included 30 eyes (10 PKP, 10 DSEK, 10 DMEK). Mean pain scores (0-100 scale; (0-39 = mild pain, 40-69 = moderate pain, 70-100 = severe pain) in the Dextenza group were 3.6 (PKP), 12 (DSEK), 8 (DMEK), compared to 1.2 (PKP), 0 (DSEK), and 4 (DMEK) in controls. PKP control (n=5): 1 delayed re-epithelialization, 1 IOP elevation, 2 CME. DSEK control (n=5): 1 corneal rejection, 1 IOP elevation, 1 CME. DMEK…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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