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

Early Phase 1

Completed

• Conditions: Cataract
• Interventions: Drug: Safety of intracameral levofloxacin in cataract surgery; Drug: Use of intracameral cefazolin in cataract surgery

• Registration Number: NCT06710977
• Lead Sponsor: Tan Tock Seng Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01
• Status Verified: 2024-10
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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
Safety of Intracameral levofloxacin in cataract surgery	Use of intracameral cefazolin in cataract surgery	Eligible and recruited patients are randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery
Use of intracameral cefazolin in cataract surgery	Safety of intracameral levofloxacin in cataract surgery	Eligible and recruited patients were randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery
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

Primary Outcome Measures

Name	Time	Method
Number of Participants with Treatment related adverse events to Intracameral Cefazolin versus Levofloxacin	From cataract surgery through to study completion, an average of 1 year

Trial Locations

Locations (2)

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore

Ang Mo Kio Specialist Center; 🇸🇬 Singapore, Singapore