Conjunctival Flora Patterns After Serial Intravitreal Injections in

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02337972
Study type	Interventional
Source	Sheba Medical Center
Contact	Irit Barequet, MD
Phone	972-52-8305302
Email	ibarequet@yahoo.com
Status	Recruiting
Phase	N/A
Start date	January 2015
Completion date	January 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03660345` - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME	Phase 3
Completed	`NCT03660384` - Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy	N/A
Completed	`NCT03660371` - ILM Peeling in PDR Patients Undergoing PPV for VH	N/A
Completed	`NCT04905459` - ARDA Software for the Detection of mtmDR
Active, not recruiting	`NCT04271709` - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)	N/A
Recruiting	`NCT03713268` - Intraoperative OCT Guidance of Intraocular Surgery II
Completed	`NCT05022615` - Comparing 3 Imaging Systems
Completed	`NCT00385333` - Metabolic Mapping to Measure Retinal Metabolism	Phase 2
Recruiting	`NCT04101604` - Biomarkers of Common Eye Diseases
Completed	`NCT03702374` - Combined Antioxidant Therapy on Oxidative Stress, Mitochondrial Dysfunction Markers in Diabetic Retinopathy	Phase 3
Completed	`NCT01908816` - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.	Phase 3
Completed	`NCT04009980` - Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus.	N/A
Completed	`NCT02924311` - Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
Not yet recruiting	`NCT06257082` - Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities	N/A
Not yet recruiting	`NCT05452993` - Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography	N/A
Withdrawn	`NCT02812030` - Aflibercept for Retinopathy in the Real World	N/A
Completed	`NCT02391558` - Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography	N/A
Active, not recruiting	`NCT02330042` - OCT Biomarkers for Diabetic Retinopathy
Active, not recruiting	`NCT02353923` - OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy	N/A
Completed	`NCT02390245` - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Conjunctival Flora Patterns After Serial Intravitreal Injections in Diabetic Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms