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Clinical Trials/NCT02337972
NCT02337972UnknownNot Applicable

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

Sheba Medical Center1 site in 1 country50 target enrollmentStarted: January 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Locations
1
Primary Endpoint
Change of conjunctival flora and bacterial resistance

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Diabetic patients

Experimental

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: povidone-iodine 4% (Drug)

Outcomes

Primary Outcomes

Change of conjunctival flora and bacterial resistance

Time Frame: 4 month

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Dr. Irina Barequet

Head of cornea unit, Ophthalmology department

Sheba Medical Center

Study Sites (1)

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