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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levofloxacin Ocular Implant | Experimental | Biphasic levofloxacin antibiotic implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levofloxacin Ocular Implant | Drug | Levofloxacin Ocular Implant an implant that delivers a bolus dose of levofloxacin and a constant daily dose for a further 5-7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Inflammation | Change assessed according to Standardization of Uveitis Nomenclature (SUN) Grading Scale | 90 days |
| Endothelial Cell Density | Change in number of central corneal endothelial cells per mm2 | 90 days |
| Intraocular Pressure (IOP) | Change in IOP measured by Goldmann applenation tonometry | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Administration procedure | Number of actuation's required to expel implant | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Gira, MD | Opthalmology Consultants Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Consultants Ltd | St Louis | Missouri | 63131 | United States | ||
| Carolina Cataract and Laser Centre |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Ladson |
| South Carolina |
| 29456 |
| United States |
| Melbourne Eye Specialists | Fitzroy | Victoria | 3065 | Australia |