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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Levofloxacin Ocular Implant an implant that delivers a bolus dose of levofloxacin and a constant daily dose for a further 5-7 days.
Ophthalmology Consultants Ltd
St Louis, Missouri, United States
Carolina Cataract and Laser Centre
Ladson, South Carolina, United States
Melbourne Eye Specialists
Fitzroy, Victoria, Australia
Ocular Inflammation
Change assessed according to Standardization of Uveitis Nomenclature (SUN) Grading Scale
Time frame: 90 days
Endothelial Cell Density
Change in number of central corneal endothelial cells per mm2
Time frame: 90 days
Intraocular Pressure (IOP)
Change in IOP measured by Goldmann applenation tonometry
Time frame: 90 days
Administration procedure
Number of actuation's required to expel implant
Time frame: 1 week
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