Ketorolac plus tobramycin/dexamethasone versus tobramycin/dexamethasone after uneventful phacoemulsification surgery: a randomized controlled trial

Abstract

Background/aims: To evaluate the benefit of adding a nonsteroid agent to an antibiotic/steroid combination after uneventful phacoemulsification, adopting a weekly follow-up, to gain insight into the optimal duration of postoperative treatment and to examine whether risk factors for inflammation exist.

Methods: Patients were randomized to (i) tobramycin 0.3%-dexamethasone 0.1%, 1 drop q.i.d. (n = 72), and (ii) a combination of tobramycin 0.3%-dexamethasone 0.1%, 1 drop q.i.d., plus ketorolac tromethamine 0.5%, 1 drop t.i.d. (n = 73). On days 7, 14, 21 and 28, the frequency of inflammation-related signs (corneal edema, conjunctival hyperemia, anterior chamber or Tyndall reaction) as well as best-corrected visual acuity (BCVA) were measured. On day 21, logistic regression was performed to evaluate risk factors for inflammation.

Results: The frequency of inflammation-related signs did not differ between the 2 groups at any time point, neither did BCVA. On day 21, pseudoexfoliation was associated with the presence of any inflammation-related sign (OR = 4.5; 95% CI: 1.2-16.0; p = 0.022). No evidence of clinically significant cystoid macular edema became evident in either group.

Conclusion: The addition of ketorolac did not seem to offer any additional benefit in terms of inflammation-related signs. Four weeks appeared as an adequate treatment interval. Special attention should be paid to patients with pseudoexfoliation.