Levofloxacin Ocular Implant for Ocular Surgery
- Registration Number
- NCT04682288
- Lead Sponsor
- PolyActiva Pty Ltd
- Brief Summary
This is a multi center, open label, interventional study in one eye of 5 subjects scheduled for uncomplicated cataract surgery with administration of a single Levofloxacin Ocular Implant in the posterior sulcus of the surgical eye at the end of cataract surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
- Diagnosis of cataract in the intent to treat eye
- Endothelial cell density in the study eye of at least 2000 cells per mm2
Exclusion Criteria
- history of ocular inflammation including, macular degeneration, uveitis, macular edema or corneal edema
- recent surgery in the study eye
- subjects receiving a glaucoma device in conjunction with cataract surgery
- subjects with a compromised posterior capsule during surgery
- corneal disease that prevents effective imaging of endothelium including Fuch's Dystrophy.
- sensitivity to fluoroquinolones
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Levofloxacin Ocular Implant Levofloxacin Ocular Implant Biphasic levofloxacin antibiotic implant
- Primary Outcome Measures
Name Time Method Endothelial Cell Density 90 days Change in number of central corneal endothelial cells per mm2
Intraocular Pressure (IOP) 90 days Change in IOP measured by Goldmann applenation tonometry
Ocular Inflammation 90 days Change assessed according to Standardization of Uveitis Nomenclature (SUN) Grading Scale
- Secondary Outcome Measures
Name Time Method Administration procedure 1 week Number of actuation's required to expel implant
Trial Locations
- Locations (3)
Ophthalmology Consultants Ltd
🇺🇸Saint Louis, Missouri, United States
Carolina Cataract and Laser Centre
🇺🇸Ladson, South Carolina, United States
Melbourne Eye Specialists
🇦🇺Fitzroy, Victoria, Australia