Diabetic Macular Edema, Diabetic Retinopathy
Conditions
Keywords
diabetic macular edema, Intravitreal injection, conjunctival flora
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.
Interventions
DRUGpovidone-iodine 4%
Prior to each injection and before the use of povidone-iodine drops, a conjunctival culture will be taken
Sponsors
Assaf-Harofeh Medical Center
Sheba Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of conjunctival flora and bacterial resistance | 4 month |
Countries
Israel
Contacts
Primary ContactIrit Barequet, MD
Backup ContactAdi Einan-Lifshitz, MD
Outcome results
None listed