A Randomized Clinical Trial of Topical Diclofenac, Fluorometholone, and Dexamethasone for Control of Inflammation After Strabismus Surgery.

Purpose: To evaluate the comparative effects and safety of topical diclofenac sodium, fluorometholone, and dexamethasone for controlling inflammation after routine strabismus surgery. Methods: This was a randomized clinical trial. Ninety-nine patients admitted for surgery to treat intermittent exotropia were randomly assigned to receive 1 of 3 postoperative eye drops between January 2015 and February 2016. The primary efficacy outcomes were pain and conjunctival injection. Pain score from 0 to 10 was evaluated in each patient at postoperative days 1, 2, 3, and 5, in addition to weeks 1, 2, and 4. Conjunctival injection was graded from 1 to 4 at postoperative weeks 1, 2, and 4. We also evaluated intraocular pressure (IOP), discomfort attributed to the drops, and development of any other side effects. Results: Conjunctival injection grade was the lowest in the diclofenac sodium group at postoperative weeks 1 and 2 (P<0.001 and P=0.03). There was no significant difference in pain score among the 3 groups. Mean IOP was the highest in the dexamethasone group at postoperative weeks 1, 2, and 4 (P<0.001, P<0.001, and P=0.02). Significant IOP elevation (>= 10 mmHg relative to preoperative IOP) was observed in 6 patients in the dexamethasone group. There was no difference in discomfort upon administration of the drops among the 3 groups, and no other adverse events developed. Conclusion: Diclofenac sodium was more effective against conjunctival injection than the 2 topical corticosteroids tested, but had a similar effect on postoperative pain as them. IOP elevation developed only in the dexamethasone group.