Cataract Senile, Endophthalmitis, Antibiotic Side Effect, Safety Issues
Conditions
Keywords
levofloxacin, moxifloxacin, prophylaxis, endophthalmitis, cataract surgery
Brief summary
Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis
Detailed description
Randomized clinical trial comparing corneal and retinal changes after intracameral levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing uncomplicated phacoemulsification.
Interventions
0.1 ml of unpreserved 0.5% levofloxacin
0.1 ml of unpreserved 0.5% moxifloxacin
Sponsors
Peregrine Eye and Laser Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
unlabelled syringe containing interventional drug
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Eyes undergoing uncomplicated cataract surgery by phacoemulsification
Exclusion criteria
* Corneal opacities, corneal dystrophies, glaucoma, uveitis, retinopathy, optic neuropathy, concomitant infection (blepharitis, hordeolum, or conjunctivitis) or uncontrolled systemic disease and intraoperative complications that may affect visual outcomes were excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial Cell Count | 3 months | Change in endothelial cell count as measured by specular microscopy |
| Central Retina Thickness | 3 months | Change in central retinal thickness as measured by spectral domain optical coherence tomography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 3 months | Onset of Adverse events following intervention |
Countries
Philippines
Outcome results
None listed