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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%
* Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tobramycin/Dexamethasone<br> | Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%<br>* one drop four times per day<br>* Other names: Tobradex;Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine<br>* Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day<br>* Other names: Acular;|
| Active Comparator: Tobramycin/Dexamethasone plus Ketorolac tromethamine<br> | Drug: Drug: Tobramycin 0.3% - Dexamethasone 0.1%<br>* one drop four times per day<br>* Other names: Tobradex;Drug: Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine<br>* Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day<br>* Other names: Acular;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity, corneal edema, Tyndall reaction, redness |  | 1,7,14,28 post-operative day, Up to 28 days |