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

NCT03420820 | Unknown

• 1 other identifier: 1162018
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Endophthalmitis; Eye Infections

Keywords

intravitreal injection; povidone-iodine; ocular surface flora; endophthalmitis; betadine

Outcome Measures

Primary Outcomes (1)

• Median Colony-Forming Units

  Median CFUs compared pre- and post-injection

  3 months

Secondary Outcomes (1)

• Patient's ocular surface symptoms during sterilization with povidone-iodine

  3 months

Study Arms (3)

5% Betadine, Ocular Surface only

EXPERIMENTAL

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

10% Betadine, Ocular Surface only

EXPERIMENTAL

Use of 10% P-I swabstick to sterilize the ocular surface only, prior to injection. Intervention: bacterial culture swab.

Biological: Bacterial Culture Swab

10% Betadine, Ocular Surface and Adnexa

EXPERIMENTAL

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

Interventions

Bacterial Culture Swab BIOLOGICAL

Culture swabs will be obtained before application of PI and after injection.

10% Betadine, Ocular Surface and Adnexa; 10% Betadine, Ocular Surface only; 5% Betadine, Ocular Surface only

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Matthew Bolton: lead

MeSH Terms

Conditions

Endophthalmitis; Eye Infections

Condition Hierarchy (Ancestors)

Infections; Eye Diseases

Study Officials

• Donald Mazzulla, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Bolton, MD

CONTACT

504-495-5631; mbolt3@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ophthalmology Resident

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 5, 2018
• Study Start: March 1, 2018
• Primary Completion: April 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share