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Evaluating a Sustained-Release Dexamethasone Insert as Adjunctive Therapy for Inflammation and Pain Post-Corneal
Hasan Alsetri1,2, Nicole Fram2,3, Orly Shiler2
1Weill Cornell Medicine-Qatar, Education City, Qatar Foundation, Doha, Qatar.
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 control (n=5): 1 IOP elevation, 1 CME. DMEK Dextenza (n=5): 1 delayed re-epithelialization, 1 CME. No cases required steroid rescue, and no cell or flare was observed one-week post-surgery. There were no statistically significant differences in pain, delayed re-epithelialization, IOP elevation, corneal rejection, or CME between the Dextenza and control groups regardless of the type of corneal transplantation performed.
Conclusion:
Dextenza, when combined with a lower-frequency drop regimen, demonstrates a safety profile comparable to that of a traditional higher-frequency drop protocol in terms of pain management and the adverse events explored in this study, potentially enhancing postoperative drop adherence.
