A Double-blind, Randomized Controlled Pilot Study Comparing the Safety and Efficacy of Intracameral Levofloxacin and Intracameral Cefazolin in Cataract Surgery
Overview
- Phase
- Early Phase 1
- Intervention
- Safety of intracameral levofloxacin in cataract surgery
- Conditions
- Cataract
- Sponsor
- Tan Tock Seng Hospital
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Number of Participants with Treatment related adverse events to Intracameral Cefazolin versus Levofloxacin
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Patients with senile cataracts undergoing phacoemulsification were assigned to receive intracameral levofloxacin (0.1ml/0.5mg) or intracameral cefazolin (0.1ml/1mg). The primary endpoint was the occurrence of endophthalmitis during the 3 month follow-up period. Secondary endpoints included best-corrected visual acuity (BVCA), the presence of anterior chamber (AC) inflammation with grading of AC cells and presence of flare, along with intraocular pressure (IOP), corneal cell thickness (CCT), central foveal thickness (CFT) and cell density.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged ≥50 to \<80 years
- •Undergoing cataract surgery under the care of one of three study investigators, all of whom were consultant level cataract surgeons
- •Only those with senile cataracts, assessed using the Lens Opacities Classification System III scale (LOCS III) and without features of complex cataracts were included
Exclusion Criteria
- •\<50 or \>80 years old
- •Prior ocular trauma, pregnant, previous history of refractive, corneal or intraocular surgery, cornea endothelial cell count \<1500/sqmm², concomitant ocular disease, allergy to penicillin, fluoroquinolone or cephalosporin, and abnormal biometric measurements
Arms & Interventions
Safety of Intracameral levofloxacin in cataract surgery
Eligible and recruited patients are randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery
Intervention: Safety of intracameral levofloxacin in cataract surgery
Safety of Intracameral levofloxacin in cataract surgery
Eligible and recruited patients are randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery
Intervention: Use of intracameral cefazolin in cataract surgery
Use of intracameral cefazolin in cataract surgery
Eligible and recruited patients were randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery
Intervention: Safety of intracameral levofloxacin in cataract surgery
Use of intracameral cefazolin in cataract surgery
Eligible and recruited patients were randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery
Intervention: Use of intracameral cefazolin in cataract surgery
Outcomes
Primary Outcomes
Number of Participants with Treatment related adverse events to Intracameral Cefazolin versus Levofloxacin
Time Frame: From cataract surgery through to study completion, an average of 1 year