drugset / Trial / NCT01103401

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

NCT01103401

Completed 145 enrolled Veroia General Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2009-10
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ketorolac Other / unclassified 0.5 % Topical
Comparator Dexamethasone Small molecule 0.1 % Topical
Comparator Tobramycin Small molecule 0.3 % Topical

Indications