Back to resultsPostoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin
Primary Purpose
Cataract Senile, Endophthalmitis, Antibiotic Side Effect
Status
Completed
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
Levofloxacin Ophthalmic
Moxifloxacin Ophthalmic
Sponsored by
About this trial
This is an interventional other trial for Cataract Senile focused on measuring levofloxacin, moxifloxacin, prophylaxis, endophthalmitis, cataract surgery
Eligibility Criteria
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
Sites / Locations
- Peregrine Eye and Laser Instittute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intracameral levofloxacin
Intracameral moxifloxacin
Arm Description
0.5% unpreserved solution
0.5% unpreserved solution
Outcomes
Primary Outcome Measures
Endothelial Cell Count
Change in endothelial cell count as measured by specular microscopy
Central Retina Thickness
Change in central retinal thickness as measured by spectral domain optical coherence tomography
Secondary Outcome Measures
Adverse Events
Onset of Adverse events following intervention
Full Information
NCT ID
NCT04403334
First Posted
May 21, 2020
Last Updated
May 21, 2020
Sponsor
Peregrine Eye and Laser Institute
1. Study Identification
Unique Protocol Identification Number
NCT04403334
Brief Title
Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin
Official Title
Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery With Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin Versus Levofloxacin
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
April 28, 2018 (Actual)
Study Completion Date
April 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peregrine Eye and Laser Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Senile, Endophthalmitis, Antibiotic Side Effect, Safety Issues
Keywords
levofloxacin, moxifloxacin, prophylaxis, endophthalmitis, cataract surgery
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
unlabelled syringe containing interventional drug
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intracameral levofloxacin
Arm Type
Experimental
Arm Description
0.5% unpreserved solution
Arm Title
Intracameral moxifloxacin
Arm Type
Experimental
Arm Description
0.5% unpreserved solution
Intervention Type
Drug
Intervention Name(s)
Levofloxacin Ophthalmic
Intervention Description
0.1 ml of unpreserved 0.5% levofloxacin
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin Ophthalmic
Intervention Description
0.1 ml of unpreserved 0.5% moxifloxacin
Primary Outcome Measure Information:
Title
Endothelial Cell Count
Description
Change in endothelial cell count as measured by specular microscopy
Time Frame
3 months
Title
Central Retina Thickness
Description
Change in central retinal thickness as measured by spectral domain optical coherence tomography
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Onset of Adverse events following intervention
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey S Uy, MD
Organizational Affiliation
Peregrine Eye and Laser Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peregrine Eye and Laser Instittute
City
Makati City
State/Province
MM
ZIP/Postal Code
1209
Country
Philippines
12. IPD Sharing Statement
Learn more about this trial
Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin
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