Prospective, Randomized, Fellow Eye-Controlled Study of Postoperative Pain and Inflammation Control with an Intracanalicular Dexamethasone 0.4 mg Ophthalmic Insert Following Small Incision Lenticule Extraction.

Purpose: To compare postoperative anterior chamber inflammation, pain, and patient preference following small incision lenticule extraction (SMILE) in eyes treated with a dexamethasone 0.4 mg intracanalicular insert (DEX) or topical prednisolone acetate (PRED). Patients and Methods: In this prospective, randomized, fellow eye-controlled trial, 20 patients underwent same-day, bilateral SMILE. One randomly-selected eye of each patient received DEX placed immediately postoperatively, and the fellow eye received topical PRED tapered over 2 weeks. Postoperative evaluations were performed on day 1, week 1, month 1, and month 3. Primary outcomes included postoperative pain, incidence of anterior chamber cell and flare, and patient preference of steroid therapy. Results: No eyes in either group had any clinically evident cell or flare at any postoperative time point. Mean pain scores (0-10 by subjective report) and incidence of any pain were statistically similar at all postoperative visits. Uncorrected distance visual acuity improved in all eyes, 91% of which achieved 20/25 or better. No eyes lost any lines of corrected distance visual acuity. Three eyes developed a steroid-related rise in intraocular pressure, all of which resolved with 2 of the 3 eyes requiring topical therapy. At 1 week, 1 month, and 3 months, 70%, 65%, and 53% of patients preferred DEX over PRED therapy, respectively. Conclusion: The DEX insert was preferred by more patients and controlled postoperative inflammation and pain comparably to topical PRED in eyes undergoing SMILE. There were no statistically significant differences in visual outcomes between the two groups.