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

NCT06710977 | Completed Early Phase 1 DMC

• 1 other identifier: 2021/00844-SSR3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Safety of Intracameral levofloxacin in cataract surgery

EXPERIMENTAL

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

Use of intracameral cefazolin in cataract surgery

ACTIVE COMPARATOR

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

Safety of intracameral levofloxacin in cataract surgery DRUG

Intracameral levofloxacin (0.1ml/0.5mg)

Safety of Intracameral levofloxacin in cataract surgery; Use of intracameral cefazolin in cataract surgery

Use of intracameral cefazolin in cataract surgery DRUG

Intracameral cefazolin (0.1ml/1mg)

Safety of Intracameral levofloxacin in cataract surgery; Use of intracameral cefazolin in cataract surgery

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (2)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Ang Mo Kio Specialist Center

Singapore, 560723, Singapore

Location

Related Publications (3)

• 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)

  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.

  PMID: 29276375 BACKGROUND

• 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.

  PMID: 41038947 DERIVED

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 2, 2024
• Study Start: January 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)