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

Sponsor

Peregrine Eye and Laser Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04403334

Collaborator

(none)

114

Enrollment

Location

Arms

3.8

Actual Duration (Months)

29.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract Senile Endophthalmitis Antibiotic Side Effect Safety Issues	Drug: Levofloxacin Ophthalmic Drug: Moxifloxacin Ophthalmic	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

unlabelled syringe containing interventional drug

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 2, 2018

Actual Primary Completion Date :

Apr 28, 2018

Actual Study Completion Date :

Apr 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intracameral levofloxacin 0.5% unpreserved solution	Drug: Levofloxacin Ophthalmic 0.1 ml of unpreserved 0.5% levofloxacin
Experimental: Intracameral moxifloxacin 0.5% unpreserved solution	Drug: Moxifloxacin Ophthalmic 0.1 ml of unpreserved 0.5% moxifloxacin

Arm

Intervention/Treatment

Experimental: Intracameral levofloxacin

0.5% unpreserved solution

Drug: Levofloxacin Ophthalmic

0.1 ml of unpreserved 0.5% levofloxacin

Experimental: Intracameral moxifloxacin

0.5% unpreserved solution

Drug: Moxifloxacin Ophthalmic

0.1 ml of unpreserved 0.5% moxifloxacin

Outcome Measures

Primary Outcome Measures

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

Adverse Events [3 months]
Onset of Adverse events following intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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