Early Inflammation Control After Trabeculectomy by Steroid and Non-steroidal Eye Drops: A Randomized Controlled Trial

Abstract

Introduction:To compare the effect of three different anti-inflammatory regimens consisting of preservative-free dexamethasone (DEX), diclofenac (DICLO) eye drops, and their combination (DEX ? DICLO) following trabeculectomy on early postoperative inflammation. Methods: A prospective randomized controlled trial. Sixty-nine patients undergoing trabeculectomy were randomized to receive either postoperative treatment with topical DEX (n = 23), topical DICLO (n = 23), or a combination of topical DEX and topical DICLO (n = 23) after trabeculectomy. The primary outcome was the anterior chamber flare measurement in the first 3 months postoperatively. Secondary outcomes included intraocular pressure, central corneal thickness, conjunctival injection, and number of cells in the anterior chamber from baseline to 3 months postoperatively.Results: Anterior chamber flare reached a maximum 1 day after trabeculectomy with an increase of 55% (95% CI 37-73%) for DEX, 64% (95% CI 47-82%) for DICLO, and 57% (95% CI 39-75%) for DEX ? DICLO and returned to near pre-operative values 6 weeks after surgery. There were no significant differences in anterior chamber flare [effect size for DICLO: 0.16 (95% CI -4.3 to 4.6), effect size for DEX ? DICLO: 0.09 (95% CI -4.1 to 4.3)], intraocular pressure, central corneal thickness, conjunctival injection, or number of cells in the anterior chamber between DEX, DICLO, or DEX ? DICLO groups. Conclusion: We found that topical diclofenac was not statistically different from topical dexamethasone in controlling early postoperative inflammation after trabeculectomy, while combining diclofenac and dexamethasone offered no added anti-inflammatory control compared to dexamethasone alone. Trial Registration: www.clinicaltrials.gov (NCT04054830).

Steroids and/or Non-Steroidal Anti-Inflammatory Drugs as Postoperative Treatment after Trabeculectomy—12-Month Results of a Randomized Controlled Trial

“…The risk of NICM may be higher after trabeculectomy due to prolonged treatment. In our study, neither corneal thinning nor any statistically significant differences in adverse events were seen between treatment groups [11]. This finding is analogous to a phacotrabeculectomy study in which NSAIDs were administered for nine weeks postoperatively [44].…”

“…A well-documented side effect of steroid treatment is the development or progression of cataract, regardless of whether it is administered topically or systemically [7][8][9][10]. Furthermore, some patients may experience increased IOP (steroid response) during treatment, despite a functioning bleb, giving the impression that the filtration surgery has failed [11][12][13][14].…”