NCT06710977

To Compare the Safety and Efficacy of Intracameral Levofloxacin and Intracameral Cefazolin in Reducing Rates of Endophthalmitis Following Cataract Surgery.

A Double-blind, Randomized Controlled Pilot Study Comparing the Safety and Efficacy of Intracameral Levofloxacin and Intracameral Cefazolin in Cataract Surgery

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Tan Tock Seng Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Safety of intracameral levofloxacin in cataract surgery	Intracameral levofloxacin (0.1ml/0.5mg)
DRUG	Use of intracameral cefazolin in cataract surgery	Intracameral cefazolin (0.1ml/1mg)

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2024-12-02
• Last updated: 2024-12-02

Locations

2 sites across 1 country: Singapore