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

NCT ID: NCT06710977

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Safety of Intracameral levofloxacin in cataract surgery

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

Group Type EXPERIMENTAL

Safety of intracameral levofloxacin in cataract surgery

Intervention Type DRUG

Intracameral levofloxacin (0.1ml/0.5mg)

Use of intracameral cefazolin in cataract surgery

Intervention Type DRUG

Intracameral cefazolin (0.1ml/1mg)

Use of intracameral cefazolin in cataract surgery

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

Group Type ACTIVE_COMPARATOR

Safety of intracameral levofloxacin in cataract surgery

Intervention Type DRUG

Intracameral levofloxacin (0.1ml/0.5mg)

Use of intracameral cefazolin in cataract surgery

Intervention Type DRUG

Intracameral cefazolin (0.1ml/1mg)

Interventions

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Safety of intracameral levofloxacin in cataract surgery

Intracameral levofloxacin (0.1ml/0.5mg)

Intervention Type DRUG

Use of intracameral cefazolin in cataract surgery

Intracameral cefazolin (0.1ml/1mg)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tan Tock Seng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tan Tock Seng Hospital

Singapore, , Singapore

Site Status

Ang Mo Kio Specialist Center

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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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)

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 29276375 (View on PubMed)

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.

Reference Type DERIVED
PMID: 41038947 (View on PubMed)

Other Identifiers

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2021/00844-SSR3

Identifier Type: -

Identifier Source: org_study_id