A Double-blind, Randomized Controlled Pilot Study Comparing the Safety and Efficacy of Intracameral Levofloxacin and Intracameral Cefazolin in Cataract Surgery
Sponsor study identifier
interventional
50
1 country
2
Study Start
January 1, 2022
Actual (reported)Primary Completion
September 1, 2024
Actual (reported)Study Completion
September 1, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2024
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2022
Actual (reported)September 1, 2024
Actual (reported)September 1, 2024
Actual (reported)November 20, 2024
Actual (reported)December 2, 2024
Actual (reported)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
Eligible and recruited patients are randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery
Eligible and recruited patients were randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery
Intracameral levofloxacin (0.1ml/0.5mg)
Intracameral cefazolin (0.1ml/1mg)
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Ang Mo Kio Specialist Center
Singapore, 560723, Singapore
Cruz FM, Uy HS, Rubio CJ, Chan PS. Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery with Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin versus Levofloxacin. Philippine Journal of Ophthalmology. 2022;47(1)
Espiritu CRG, Bolinao JG. Prophylactic intracameral levofloxacin in cataract surgery - an evaluation of safety. Clin Ophthalmol. 2017 Dec 12;11:2199-2204. doi: 10.2147/OPTH.S144625. eCollection 2017.
Koh YT, Yeo TK, Toh ZH, Wong JXH, Ngo WK, Fam HB, Pek DCK. A double-blind, randomized controlled pilot study comparing the safety of intracameral levofloxacin and intracameral cefazolin in patients undergoing cataract surgery. Sci Rep. 2025 Oct 2;15(1):34444. doi: 10.1038/s41598-025-17553-6.
50 participants (actual enrollment reported by the registry).
First Submitted
November 20, 2024
First Posted
December 2, 2024
Study Start
January 1, 2022
Actual (reported)Comparison of Wound Integrity for Clear Corneal Cataract Incisions
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Primary Completion
September 1, 2024
Actual (reported)Study Completion
September 1, 2024
Actual (reported)Last Updated
December 2, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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