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

• Status: Completed
• Trial end date: 2010-01-01
• 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.

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.

• 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:

• 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