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

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).