Povidone Iodine vs AVEnova: A Pre-injection Disinfection Study (PAVE Study) (PAVE)

March 6, 2020 updated by: Robert Avery, California Retina Consultants
To compare the efficacy and comfort of two FDA approved pre-injection antiseptics when used for intravitreal injections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intravitreal injection of medicine has become the most common ocular procedure billed to Medicare. One of the main problems with this procedure is the postoperative discomfort due to the need to disinfect the eye with Povidone Iodine (PI). This disinfectant lowers the risk of endophthalmitis, but is very rough on the corneal epithelium, producing a type of corneal abrasion in many patients that is very uncomfortable in the first few days after injection. Many patients refuse the PI disinfection even though avoiding it increases the risk of endophthalmitis with the procedure. Recently another disinfectant has been FDA approved specifically for the eye to treat blepharitis and dry eye. Avenova (Av), a dilute solution of hypochlorous acid, is used several times a day for these conditions. Some practices have begun using it for PI sensitive patients before an intravitreal injection as it is FDA-approved for disinfecting peri-ocular structures. A recent in vitro study was published showing that it is superior to PI in kill times for bacteria cultured for endophthalmitis cases. Some physicians say it is superior to PI with respect to patient comfort, however, to date, there is little literature about its use for intravitreal injection. The objective of this study is to assess comfort levels between the two FDA-approved disinfection options and to compare disinfection rates between PI and Av. The hypothesis is that Av will be as effective or more effective in elimination ocular pathogens as PI and will be significantly more comfortable for patients.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must be receiving same day bilateral injections of an anti-VEGF agent for any ophthalmic condition.
  • Subject must be fluent in English.

Exclusion Criteria:

  • Under 18 years old.
  • Subjects with an allergy or adverse reaction to Povidone Iodine or Avenova.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open label test arm
Subjects will have their right eye treated with 5% Povidone Iodine per standard institutional protocol prior to receiving their intravitreal injection (2 drops of PI followed by application of 3.5% non-preserved lidocaine gel for 10 minutes, followed by 1 drop of PI for 30 seconds prior to injection). Subjects will have their left eye treated with Avenova per the same application protocol as PI prior to receiving their intravitreal injection. Prior to and following disinfecting both eyes but before the injection, a physician will gently swab the inferior conjunctival fornix (white part of each eye below the lower eye lid) with an ocular brush. Swabs will be cultured to compare bacterial counts. Subjects will be asked to complete a questionnaire regarding comfort of the disinfectant and injection procedure in general immediately following the injection and 1-2 hours post-injection.
Other: Povidone Iodine
FDA-approved disinfectant for intravitreal injections
Other: Hypochlorous Acid
FDA-approved disinfectant for intravitreal injections
Other Names:
  • Avenova

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort of Povidone Iodine vs Avenova immediately post-treatment based on an 11-point numerical scale (0-10, with 0 being no pain, and 10 being extreme pain)
Time Frame: Immediately following the subject's injection.
Reported comfort levels will be collected immediately after the injection procedure. Average reported comfort levels in the Povidone Iodine group will be compared with average reported comfort levels from the Avenova group at each time point using a paired Student's T-test.
Immediately following the subject's injection.
Comfort of Povidone Iodine vs Avenova 1-2 hours post treatment based on an 11-point numerical scale (0-10, with 0 being no pain, and 10 being extreme pain)
Time Frame: 1-2 hours post-injection.
Reported comfort levels will be collected 1-2 hours post-injection. Average reported comfort levels in the Povidone Iodine group will be compared with average reported comfort levels from the Avenova group at each time point using a paired Student's T-test.
1-2 hours post-injection.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in colony forming unit (CFU) growth pre- and post-treatment with Povidone Iodine or Avenova to determine if Avenova is non-inferior to Povidone Iodine for ocular disinfection.
Time Frame: Two time points: 30 seconds before disinfection starts (time point 0); and after the 10 minutes disinfection period and prior just prior to the injection (time point 1).
Conjunctival swabs will be taken pre- and post-ocular disinfection and plated on Chocolate agar and blood agar. After incubating for 48 hours, average colony forming units from each agar type will be counted and the average of the ratio of [post-disinfection/pre-disinfection] will be compared between the Povisone Iodine treated eyes and the Avenova treated eyes for each agar type using a paired Student's T-Test.
Two time points: 30 seconds before disinfection starts (time point 0); and after the 10 minutes disinfection period and prior just prior to the injection (time point 1).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Retina Consultants

Investigators

  • Principal Investigator: Robert Avery, MD, California Retina Consultants

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2019

Primary Completion (Actual)

August 14, 2019

Study Completion (Actual)

August 14, 2019

Study Registration Dates

First Submitted

July 5, 2019

First Submitted That Met QC Criteria

July 11, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAVE study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

we do not plan to share IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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