Status:
COMPLETED
Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Post Operative Inflammation in LASIK Surgery
Lead Sponsor:
Federal University of São Paulo
Conditions:
Post Lasik Surgery Inflammation
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Efficacy/Safety of antibiotic steroid combination compared with individual administration in inflammation Post-LASIK
Detailed Description
antibiotic/steroid combination compared to individuals components 15 days of treatment
Eligibility Criteria
Inclusion
- patients having LASIK surgery;
- men or women of any race, between 18 and 50 years old, presenting up to 8 degrees of myopia or up to 4 degrees of hypermetropia, or up to 3 degrees of astigmatism, without any other associated ocular problems
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00330824
Start Date
April 1 2006
End Date
December 1 2006
Last Update
August 7 2009
Active Locations (1)
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1
Dept. of Ophthalmology - Rua Botucatu 824
São Paulo, São Paulo, Brazil, 04023-062