Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Postoperative Inflammation in Cataract Surgery

Study Overview
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Brief Summary
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efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Detailed Description
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Study of 15 +-1 day, double-masked, randomized, two arms, parallel groups to confirm the efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Official Title
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Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Postoperative Inflammation in Patients Having Cataract Surgery

Conditions
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Inflammation Following Cataract Surgery

Intervention / Treatment
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* Drug: antibiotic/steroid combination
* Drug: moxifloxacin / dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients having cataract surgery Exclusion Criteria: Uncontrolled glaucoma or intraocular hypertension; Use of any ocular anti-infectious drugs or any topical or systemic ocular NSAIDs during the study but study drugs; A history of chronic or recurrent ocular inflammatory disease; Uncontrolled diabetes mellitus and diabetic retinopathy ; Patients with sight in a single eye; Iris atrophy in the eye to be operated; Pregnant or lactating women, or women of childbearing potential who are not using proper birth-control methods; Known or suspected allergy or hypersensitivity to any component of study medication; A history or any other evidence of severe systemic disease

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: antibiotic steroid drops/single vial<br>efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery | Drug: antibiotic/steroid combination<br>* 1 gtt, 4x/day, 15 days<br>* Other names: moxifloxacin / dexamethasone;|
| Active Comparator: antibiotic steroids drops<br>efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery | Drug: moxifloxacin / dexamethasone<br>* 1 gtt 4x/day, 15 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| day 15 evaluation of anterior chamber |  | 15 days pos-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score |  | 15 days pos-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention of post inflammation in cataract surgery