Inflammation Following Cataract Surgery
Conditions
Keywords
prevention of post inflammation in cataract surgery
Brief summary
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery
Detailed 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
Interventions
1 gtt, 4x/day, 15 days
DRUGmoxifloxacin / dexamethasone
1 gtt 4x/day, 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 No maximum
Healthy volunteers
No
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
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