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

Safety Issues Clinical Trial

Official title:

Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery With Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin Versus Levofloxacin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04403334
• Other study ID #: 20180101
• Status: Completed
• Phase: Phase 4
• Start date: January 2, 2018
• Est. completion date: April 28, 2018

Study information

• Verified date: May 2020
• Source: Peregrine Eye and Laser Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: April 28, 2018
• Est. primary completion date: April 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Side Effect
• Cataract
• Cataract Senile
• Endophthalmitis
• Safety Issues

Intervention

Drug:
• Levofloxacin Ophthalmic
0.1 ml of unpreserved 0.5% levofloxacin
• Moxifloxacin Ophthalmic
0.1 ml of unpreserved 0.5% moxifloxacin

Locations

Country	Name	City	State
Philippines	Peregrine Eye and Laser Instittute	Makati City	MM

Sponsors (1)

Lead Sponsor	Collaborator
Peregrine Eye and Laser Institute

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Cell Count	Change in endothelial cell count as measured by specular microscopy	3 months
Primary	Central Retina Thickness	Change in central retinal thickness as measured by spectral domain optical coherence tomography	3 months
Secondary	Adverse Events	Onset of Adverse events following intervention	3 months