Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery

Ketorolac Plus Tobramycin/Dexamethasone vs. Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery

This randomized controlled trial compares two regimens of topical therapy:

• tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day
• combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day.

Patients are independently assessed by two ophthalmologists. On days 7,14,21,28 patients are evaluated for

• corneal edema
• conjunctival hyperemia
• anterior chamber (Tyndall) reaction.

The investigators purpose was to evaluate the benefit of adding a non-steroid 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.

Patients were randomized to: i) tobramycin 0.3% - dexamethasone 0.1% one drop qid (TD group, n=72, 28 days) and ii) combination of tobramycin 0.3% - dexamethasone 0.1%, one drop qid, plus Ketorolac tromethamine 0.5%, one drop tid (TD-K group, n=73, 28 days). Patients undergoing vitrectomy due to posterior capsule rupture were excluded. On days 7, 14, 21, 28, the frequency of inflammation-related signs [corneal edema, conjunctival hyperemia, anterior chamber (Tyndall) reaction], as well as the best corrected visual acuity (BCVA) were measured. On day 21, logistic regression was performed to evaluate risk factors for inflammation.

Inclusion Criteria:

• phacoemulsification (due to cataract)
• uneventful phacoemulsification surgery

Exclusion Criteria:

• history of intraocular surgery in the operated eye,
• any previous episode of uveitis in the operated eye,
• severe systemic disease (heart failure NYHA stage III of IV, end-stage renal failure, pulmonary failure, patients receiving chemotherapy),
• regular, systemic use of steroid or non-steroid anti-inflammatory drugs during the last three months
• disruption of the anterior lens capsule