CompletedEarly Phase 1

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

Singapore50 participantsStarted 2022-01-01

Plain-language 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.

Who can participate

Age range50 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants with Treatment related adverse events to Intracameral Cefazolin versus Levofloxacin

Timeframe: From cataract surgery through to study completion, an average of 1 year

Trial details

NCT IDNCT06710977

SponsorTan Tock Seng Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01