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This is a research study to evaluate the effects of repeated intravitreal injections on bacteria around the eye.
The primary objective of this study is to determine whether conjunctival bacterial flora are altered and/or demonstrate increasing antibiotic resistance after serial intravitreal injections when a prophylactic topical antibiotic is used pre- and post-injection compared to when they are not used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical antibiotic | Experimental | Patients will be randomized in a 1:1 fashion to receive a drop of topical antibiotic before and after the intravitreal injection in the +ABX arm (in addition to the typical prep with betadine). |
|
| No Antibiotic Arm | Other | No topical antibiotics in the -ABX arm (only the typical prep with betadine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conj flora Antibiotic resistance | Procedure | Patients will either receive a drop of topical antibiotic before and after the intravitral injection or no topical antibiotics (only typical prep with betadine). |
| Measure | Description | Time Frame |
|---|---|---|
| Determine if conj bacterial flora demonstrates increased antibiotic resistance if topical antibiotic used pre and post injection vs not used. | Evaluating the effects of repeated use of iodine drops with or without antibiotic eye drops on bacteria on the eye surface in patients undergoing injections in the eye to determine if conjunctival bacterial floar are altered or demonstate increasing antibiotic resistance. | Prior to each of your eye injections for the first 4 injections and continue through the completion of your fourth injection, an anticipated maximum of 6 months. |
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Inclusion Criteria: Subjects will be eligible if the following criteria are met:
Exclusion Criteria: Subjects meeting any of the following criteria are ineligible for study entry:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Hsu, MD | Mid Atlantic Retina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Institute | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 18, 2013 | |
| Reset | Jan 8, 2014 | |
| Release | Sep 16, 2018 |
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| Reset | Feb 8, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 18, 2013 | Jan 8, 2014 | |||
| Sep 16, 2018 | Feb 8, 2019 |
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D020256 | Choroidal Neovascularization |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012162 | Retinal Degeneration |
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