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CompletedNCT06710977Updated Dec 2, 2024

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

An Early Phase 1 interventional study of Safety of intracameral levofloxacin in cataract surgery and Use of intracameral cefazolin in cataract surgery in Cataract, sponsored by Tan Tock Seng Hospital. Completed at 2 sites in Singapore. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-02.

Sponsored by Tan Tock Seng Hospital · Early Phase 1, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Jan 2022, registered Nov 2024).
Phase
Early Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
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Study 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.

02

Conditions studied

  • Cataract

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03

In context

Cataract

1,726 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 1,171 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Tan Tock Seng Hospital is the lead sponsor of 108 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Safety of Intracameral levofloxacin in cataract surgery

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

    Drug: Safety of intracameral levofloxacin in cataract surgery · Drug: Use of intracameral cefazolin in cataract surgery

  • Active comparator
    Use of intracameral cefazolin in cataract surgery

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

    Drug: Safety of intracameral levofloxacin in cataract surgery · Drug: Use of intracameral cefazolin in cataract surgery

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)

06

What researchers measure

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

07

Study locations

2 sites
  • Tan Tock Seng Hospital
    Singapore, 308433, Singapore
  • Ang Mo Kio Specialist Center
    Singapore, 560723, Singapore
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References and documents

Publications

  • 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. PubMed 29276375 ↗
  • 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. PubMed 41038947 ↗

Individual participant data

Plan to share: No — Upon publication, we will be providing contact details such that keen parties can approach us to get clarification or access to the data.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06710977
Responsible party
Sponsor
First posted
Dec 2, 2024
Start date
Jan 1, 2022
Primary completion
Sep 1, 2024
Completion
Sep 1, 2024
Last update
Dec 2, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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