Concentrating on Antisepsis: 5% vs. 10% Povidone-Iodine Prior to Intravitreal Injection

This is a randomized controlled single blind prospective study evaluating the efficacy of ocular surface sterilization between three different povidone-iodine preparation techniques prior to intravitreal injection. The primary end point is significant different between median colony-forming units pre- and post-sterilization and injection.

Study Overview

• Status: Unknown
• Conditions: Endophthalmitis; Eye Infections
• Intervention / Treatment: Biological: Bacterial Culture Swab

Detailed Description

Introduction: An estimated 5.9 - 7.9 million intravitreal injections (IVI) were given in 2016. While the incidence of post-injection endophthalmitis is exceedingly low, it is a feared complication of the procedure. 96% of culture-positive post-injection endophthalmitis cases are caused by conjunctival commensals, emphasizing the importance of ocular surface sterilization prior to IVI. The most recently published guidelines for IVI state that "Povidone-Iodine (5-10%) should be the last agent applied to the intended injection site before the injection," a recommendation that is universally followed. However, there is no standard of care regarding the concentration of PI nor the field of sterilization (e.g, cleaning the eyelids and lashes), and technique varies widely in clinical practice. The literature reveals no direct comparison of 5% vs 10% PI in the context of intravitreal injection.

Methods: Single-center randomized prospective trial enrolling patients into three protocols: 5% P-I applied to ocular surface from bottle, 10% P-I swabstick applied to ocular surface, and 10% P-I swabstick applied to lids, lashes, and ocular surface. Pre-procedure cultures will be obtained from the ocular surface, and a second culture will be taken following antisepsis, injection, and irrigation. Standard microbiologic techniques will be used to collect, culture, identify, and quantify ocular surface bacteria counts. Kruskal Wallis test will be used to assess significant difference between median bacterial loads at baseline and post-cleaning, as well as median reduction from baseline. Chi-squared test will be used to assess significant difference between reduction in number of patients with specific bacteria. Following injection, a patient survey will be administered to compare patients' subjective symptoms of ocular surface irritation during the PI preparation phase of the procedure.

Conclusions: The investigators anticipate that no significant difference exists in decrease of median CFUs between the three protocols, and that lower concentration of P-I provides a more comfortable patient experience.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Bolton, MD; Phone Number: 504-495-5631; Email: mbolt3@lsuhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• enrollment will be open to men and women of all ethnic backgrounds between the ages of 18-100 who are offered intravitreal injections by Dr. Anthony Mazzulla at his Retina clinic at the Ochsner Clinic Foundation as a treatment for diabetic macular edema, proliferative diabetic retinopathy, age related exudative macular degeneration, or any other cause of choroidal neovascularization or cystoid macular edema.

Exclusion Criteria:

• Current eye infection, actively treated blepharitis, current use of topical or systemic antimicrobial agents, current use of topical or systemic corticosteroids, allergy to iodine, pregnancy, children.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5% Betadine, Ocular Surface only; Use of 5% P-I from bottle dropper to sterilize the ocular surface only, prior to injection. Intervention: bacterial culture swab.	Biological: Bacterial Culture Swab; Culture swabs will be obtained before application of PI and after injection.
Experimental: 10% Betadine, Ocular Surface only; Use of 10% P-I swabstick to sterilize the ocular surface only, prior to injection. Intervention: bacterial culture swab.	Biological: Bacterial Culture Swab; Culture swabs will be obtained before application of PI and after injection.
Experimental: 10% Betadine, Ocular Surface and Adnexa; Use of 10% P-I swabstick to sterilize the ocular surface and surrounding lids and eyelashes only, prior to injection. Intervention: bacterial culture swab.	Biological: Bacterial Culture Swab; Culture swabs will be obtained before application of PI and after injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Colony-Forming Units	Median CFUs compared pre- and post-injection	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's ocular surface symptoms during sterilization with povidone-iodine	Survey-based	3 months

Collaborators and Investigators

• Sponsor: Matthew Bolton
• Investigators: Principal Investigator: Donald Mazzulla, MD, Ochsner Health System

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 28, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: January 28, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: intravitreal injection; povidone-iodine; endophthalmitis; ocular surface flora; betadine
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Eye Infections; Endophthalmitis
• Other Study ID Numbers: 1162018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No