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Conjunctival Flora Patterns After Serial Intravitreal Injections in Diabetic Patients

Primary Purpose

Diabetic Retinopathy, Diabetic Macular Edema

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
povidone-iodine 4%
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetic Retinopathy focused on measuring diabetic macular edema, Intravitreal injection, conjunctival flora

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diabetic patients

Arm Description

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

Outcomes

Primary Outcome Measures

Change of conjunctival flora and bacterial resistance

Secondary Outcome Measures

Full Information

First Posted
January 1, 2015
Last Updated
February 19, 2015
Sponsor
Sheba Medical Center
Collaborators
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02337972
Brief Title
Conjunctival Flora Patterns After Serial Intravitreal Injections in Diabetic Patients
Official Title
Conjunctival Flora Patterns After Serial Intravitreal Injections Without Postinjection Topical Antibiotics in Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Diabetic Macular Edema
Keywords
diabetic macular edema, Intravitreal injection, conjunctival flora

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetic patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
povidone-iodine 4%
Other Intervention Name(s)
Wokadine, Pyodine
Intervention Description
Prior to each injection and before the use of povidone-iodine drops, a conjunctival culture will be taken
Primary Outcome Measure Information:
Title
Change of conjunctival flora and bacterial resistance
Time Frame
4 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irit Barequet, MD
Phone
972-52-8305302
Email
ibarequet@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adi Einan-Lifshitz, MD
Phone
972-50-5191213
Email
adi.einan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irit Barequet, MD
Organizational Affiliation
Sheba medical center, Ophthalmology department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Tel Hashomer
State/Province
Non-US Resident
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irit Bareque, MD
Phone
972-52-8305302
Email
ibarequet@yahoo.com
First Name & Middle Initial & Last Name & Degree
Adi Einan-Lifshitz, MD
Phone
972-50-5191213
Email
adi.einan@gmail.com

12. IPD Sharing Statement

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Conjunctival Flora Patterns After Serial Intravitreal Injections in Diabetic Patients

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