Skip to main content
OpenTrials
Completed

NCT Number: NCT06710977

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ang Mo Kio Specialist Center, Singapore

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Safety of intracameral levofloxacin in cataract surgery

Drug

Intracameral levofloxacin (0.1ml/0.5mg)

Use of intracameral cefazolin in cataract surgery

Drug

Intracameral cefazolin (0.1ml/1mg)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.