Post Lasik Surgery Inflammation
Conditions
Keywords
prevention of post inflammation in LASIK surgery
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
Interventions
1gtt, 4x/d, 15 days
DRUGmoxifloxacin/dexamethasone
1gtt, 4x/days, 15 days
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| day 15 evaluation of anterior chamber | 15 days pos-op |
Secondary
| Measure | Time frame |
|---|---|
| day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score | 15 days pos-op |
Countries
Brazil
Outcome results
None listed