A Research Study to Evaluate the Effects of Repeated Intravitreal Injections on Bacteria Around the Eye

Mid Atlantic Retina30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Central Retinal Vein Occlusion Choroidal Neovascularization Age-related Macular Degeneration Branch Retinal Vein Occlusion

Interventions

Conj flora Antibiotic resistancePROCEDURE

Patients will either receive a drop of topical antibiotic before and after the intravitral injection or no topical antibiotics (only typical prep with betadine).

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Wills Eye Institute

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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