Impact of dexamethasone intraocular suspension 9% on intraocular pressure after routine cataract surgery: post hoc analysis.

PURPOSE: To characterize intraocular pressure (IOP) response after treatment with dexamethasone intraocular suspension 9% vs placebo (vehicle) injection or topical prednisolone acetate 1% and to identify factors associated with increased IOP after cataract surgery.

SETTING

Data were pooled from two multicenter phase 3 clinical trials of patients undergoing routine cataract surgery.

DESIGN

Randomized, double-blind study and open-label study.

METHODS

Subjects were randomized to treatment with dexamethasone intraocular suspension or placebo in the double-blind study 1 and to dexamethasone intraocular suspension or topical prednisolone acetate in the open-label study 2. Subjects who experienced 10 mm Hg or greater, 15 mm Hg or greater, or 20 mm Hg or greater postoperative IOP increase from baseline were stratified by baseline IOP. Univariate and multivariate logistic regression models of patient variables were applied to identify independent risk factors predictive of IOP elevation of 10 mm Hg or greater or 15 mm Hg or greater.

RESULTS

The study comprised 414 subjects. Dexamethasone intraocular suspension was associated with a slightly higher mean IOP at the first postoperative visit vs prednisolone (P < .05); however, mean IOP was not statistically different between the 2 groups by postoperative day 8 (P = .5006) or thereafter. Univariate analysis showed that both prednisolone and dexamethasone intraocular suspension increased risk for postoperative IOP elevation compared with placebo; however, there was no statistically significant increased risk with dexamethasone intraocular suspension vs prednisolone. Aside from antiinflammatory treatment, risk factors for postoperative IOP elevation by univariate and multivariate analyses were higher baseline IOP, high myopia, and, when defining IOP increase as 15 mm Hg or greater from baseline, male sex.

CONCLUSIONS

Dexamethasone intraocular suspension was associated with IOP elevation patterns comparable with topical prednisolone. High myopia, higher baseline IOP, and male sex were significant predictors of postoperative IOP elevation in this cohort.