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

Federal University of São Paulo

Status: Completed

Conditions: Inflammation Following Cataract Surgery

Treatments: Drug: moxifloxacin / dexamethasone; Drug: antibiotic/steroid combination

Study type: Interventional

Funder types: Other

Identifiers

NCT00331084

BRA-05-01

Details and patient eligibility

About

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

Full description

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

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

antibiotic steroid drops/single vial

Experimental group

Description:

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

Treatment:

Drug: antibiotic/steroid combination

antibiotic steroids drops

Active Comparator group

Description:

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

Treatment:

Drug: moxifloxacin / dexamethasone