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

Tan Tock Seng Hospital

Status and phase: Completed; Early Phase 1

Conditions: Cataract

Treatments: Drug: Safety of intracameral levofloxacin in cataract surgery; Drug: Use of intracameral cefazolin in cataract surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06710977

2021/00844-SSR3

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Safety of Intracameral levofloxacin in cataract surgery

Experimental group

Description:

Eligible and recruited patients are randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery

Treatment:

Drug: Use of intracameral cefazolin in cataract surgery

Drug: Safety of intracameral levofloxacin in cataract surgery

Use of intracameral cefazolin in cataract surgery

Active Comparator group

Description:

Eligible and recruited patients were randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery

Treatment:

Drug: Use of intracameral cefazolin in cataract surgery

Drug: Safety of intracameral levofloxacin in cataract surgery