Conjunctival Flora Patterns After Serial Intravitreal Injections in Diabetic Patients

February 19, 2015 updated by: Dr. Irina Barequet, Sheba Medical Center

Conjunctival Flora Patterns After Serial Intravitreal Injections Without Postinjection Topical Antibiotics in Diabetic Patients

The aim of this study is to investigate the conjunctival bacterial flora and antibiotic resistance patterns following serial intravitreal injections of anti-VEGF in diabetic patients, using a povidone-iodine preparation without preinjection or postinjection topical antibiotics.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study is designed to enroll patients with Diabetes Mellitus over 18 years of age with diagnosis of diabetic retinopathy and diabetic macular edema, who were determined by their treating physician to require at least 3 serial injections with an anti-VEGF agent.

After signing an informed consent, conjunctival cultures will be performed from the participants' both eyes at baseline and at each subsequent injection. Prior to each injection and the use of povidone-iodine drops, a conjunctival culture will be taken by swabbing the inferior fornix. Another culture will be taken twenty minutes after the injection. We will culture the swab samples on blood and chocolate agar plates.

All patients will be asked to complete a questionnaire regarding their signs and symptoms after the injection (like burning sensation, itching, discharge, tearing etc). The following routine procedure will be used in all intravitreal injections: local anesthesia using Oxybuprocaine hydrochloride, ocular surface and eyelids sterilization with topical povidone-iodine 4%. Intravitreal injection of 3.5 mm will be performed posterior to the limbus in pseudophakic patients and 4 mm injection will be performed posterior to the limbus in phakic patients using a 30 gauge needle.

The exclusion criteria will consist patients who had received a prior intraocular injection in either eye, current use of contact lenses, chronic use of any ophthalmic medication, ocular surgery within the past 6 months, use of systemic antibiotics within the past 6 months and known allergy or contraindication to povidone-iodine or proparacaine.

The study is planned to enroll 50 patients.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Non-US Resident
      • Tel Hashomer, Non-US Resident, Israel, 52621
        • Recruiting
        • Sheba Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age above 18
  • patients with diabetes mellitus
  • patients with diabetic macular edema

Exclusion Criteria:

  • patients who had received a prior intraocular injection in either eye,
  • current use of contact lenses,
  • chronic use of any ophthalmic medication,
  • ocular surgery within the past 6 months,
  • use of systemic antibiotics within the past 6 months,
  • known allergy or contraindication to povidone-iodine or proparacaine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetic patients
Patients with Diabetes Mellitus and macular edema who were determined by their treating physician to require at least 3 serial injections with an anti-Vascular epithelial growth factor (VEGF). Prior to each injection a use of povidone-iodine 4% drops will be performed to clean the conjunctival sac
Drug: povidone-iodine 4%
Prior to each injection and before the use of povidone-iodine drops, a conjunctival culture will be taken
Other Names:
  • Wokadine
  • Pyodine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of conjunctival flora and bacterial resistance
Time Frame: 4 month
4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Irit Barequet, MD, Sheba medical center, Ophthalmology department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

January 1, 2015

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 14, 2015

Study Record Updates

Last Update Posted (Estimate)

February 20, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sheba_Medical_Center

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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