Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin

Phase 4

Completed

• Conditions: Cataract Senile; Endophthalmitis; Safety Issues; Antibiotic Side Effect
• Interventions: Drug: Moxifloxacin Ophthalmic; Drug: Levofloxacin Ophthalmic

• Registration Number: NCT04403334
• Lead Sponsor: Peregrine Eye and Laser Institute

Brief Summary

Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis

Detailed Description

Randomized clinical trial comparing corneal and retinal changes after intracameral levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing uncomplicated phacoemulsification.

Study Timeline

• Study Start: 2018-01-02
• Primary Completion: 2018-04-28
• Study Completion: 2018-04-28
• Status Verified: 2020-05
• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-21
• Last Update Submitted: 2020-05-21
• Study First Posted: 2020-05-27
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Eyes undergoing uncomplicated cataract surgery by phacoemulsification

Exclusion Criteria

• Corneal opacities, corneal dystrophies, glaucoma, uveitis, retinopathy, optic neuropathy, concomitant infection (blepharitis, hordeolum, or conjunctivitis) or uncontrolled systemic disease and intraoperative complications that may affect visual outcomes were excluded from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracameral moxifloxacin	Moxifloxacin Ophthalmic	0.5% unpreserved solution
Intracameral levofloxacin	Levofloxacin Ophthalmic	0.5% unpreserved solution

Primary Outcome Measures

Name	Time	Method
Endothelial Cell Count	3 months	Change in endothelial cell count as measured by specular microscopy
Central Retina Thickness	3 months	Change in central retinal thickness as measured by spectral domain optical coherence tomography

Secondary Outcome Measures

Name	Time	Method
Adverse Events	3 months	Onset of Adverse events following intervention

Trial Locations

Locations (1)

Peregrine Eye and Laser Instittute; 🇵🇭 Makati City, MM, Philippines