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

Sponsor

Mid Atlantic Retina (Other)

Overall Status

Unknown status

CT.gov ID

NCT01531842

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a research study to evaluate the effects of repeated intravitreal injections on bacteria around the eye.

Condition or Disease	Intervention/Treatment	Phase
Central Retinal Vein Occlusion Choroidal Neovascularization Age-related Macular Degeneration Branch Retinal Vein Occlusion	Procedure: Conj flora Antibiotic resistance	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Bacterial Resistance and Alterations in Conjunctival Flora Following Serial Intravitreal Injections

Study Start Date :

Aug 1, 2011

Anticipated Primary Completion Date :

Feb 1, 2013

Anticipated Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Topical antibiotic 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).	Procedure: Conj 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).
Other: No Antibiotic Arm No topical antibiotics in the -ABX arm (only the typical prep with betadine)	Procedure: Conj 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).

Arm

Intervention/Treatment

Experimental: Topical antibiotic

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).

Procedure: Conj 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).

Other: No Antibiotic Arm

No topical antibiotics in the -ABX arm (only the typical prep with betadine)

Procedure: Conj 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).

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.