Evaluating a Sustained-Release Dexamethasone Insert as Adjunctive Therapy for Inflammation and Pain Post-Corneal Transplantation.

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.