Age-related Macular Degeneration, Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, Choroidal Neovascularization
Conditions
Keywords
Conjunctival bacterial flora, prophylactic topical antibiotic, injection, intravitreal injection, bacterial resistance, serial injection, serial intravitreal injections, CNV, CRVO, AMD, BRVO
Brief summary
This is a research study to evaluate the effects of repeated intravitreal injections on bacteria around the eye.
Detailed description
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.
Interventions
PROCEDUREConj flora Antibiotic resistance
Patients will either receive a drop of topical antibiotic before and after the intravitral injection or no topical antibiotics (only typical prep with betadine).
Sponsors
Mid Atlantic Retina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Subjects will be eligible if the following criteria are met: * Ability to provide written informed consent and comply with study assessments for the full duration of the study. * Have been diagnosed with neovascular AMD, CRVO or BRVO. * Have been determined by the investigator to require intravitreal injections of bevacizumab or ranibizumab.
Exclusion criteria
Subjects meeting any of the following criteria are ineligible for study entry: * Prior intraocular injection in either eye. * Chronic use of opthalmic medication. * Contact lens wear. * Ocular surgery within the past 6 months. * Use of ophthalmic medications in either eye or ocular infection within the past 6 months. * Use of systemic antibiotics within 6 months. * Known allergy or contraindication to povidone iodine or fluoroquinolones.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine if conj bacterial flora demonstrates increased antibiotic resistance if topical antibiotic used pre and post injection vs not used. | 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. | 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. |
Countries
United States
Outcome results
None listed