Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Drug: Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%; Drug: Tobramycin 0.3% - Dexamethasone 0.1%

• Registration Number: NCT00992355
• Lead Sponsor: Veroia General Hospital

Brief 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. The topical treatment is administered for 28 days after phacoemulsification.

Patients are independently assessed by two ophthalmologists. On day 28, patients are evaluated for

* corneal edema

* conjunctival redness

* anterior chamber reaction. Moreover, the cases necessitating continuation of treatment are compared in the two groups on day 28 and 42.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Status Verified: 2009-10
• Study First Submitted: 2009-10-08
• Study First Submitted QC: 2009-10-08
• Last Update Submitted: 2009-10-08
• Study First Posted: 2009-10-09
• Last Update Posted: 2009-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Phacoemulsification (due to cataract)
• Uneventful phacoemulsification surgery

Exclusion Criteria

• Disruption of the anterior lens capsule
• Age-related macular degeneration
• Proliferative diabetic retinopathy
• Glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tobramycin-Dexamethasone plus Ketorolac tromethamine	Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%	-
Tobramycin 0.3% - Dexamethasone 0.1%	Tobramycin 0.3% - Dexamethasone 0.1%	-

Trial Locations

Locations (1)

Department of Ophthalmology, Veroia General Hospital; 🇬🇷 Veroia, Greece