NCT01103401

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Veroia General Hospital · Academic / Other
• Sex: All
• Age: 55 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Drug: Tobramycin 0.3% - Dexamethasone 0.1%	one drop four times per day
DRUG	Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine	Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2010-04-14
• Last updated: 2015-04-15