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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Veroia General Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ketorolac; Ketorolac Tromethamine; Tobramycin

Criteria

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