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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
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06710977
Enrollment
50
Registered
2024-12-02
Start date
2022-01-01
Completion date
2024-09-01
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

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.

Interventions

DRUGSafety of intracameral levofloxacin in cataract surgery

Intracameral levofloxacin (0.1ml/0.5mg)

DRUGUse of intracameral cefazolin in cataract surgery

Intracameral cefazolin (0.1ml/1mg)

Sponsors

Tan Tock Seng Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of Participants with Treatment related adverse events to Intracameral Cefazolin versus LevofloxacinFrom cataract surgery through to study completion, an average of 1 year

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026