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

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ClinicalTrials.gov Identifier: NCT04018482
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Avery, California Retina Consultants

Brief Summary:
To compare the efficacy and comfort of two FDA approved pre-injection antiseptics when used for intravitreal injections.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Diabetic Retinopathy Diabetic Macular Edema Other: Povidone Iodine Other: Hypochlorous Acid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A single cohort will have one eye (right) treated with Povidone Iodine (PI), and one eye (left) treated with Avenova.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Povidone Iodine vs AVEnova: A Pre-injection Disinfection Study (PAVE Study)
Estimated Study Start Date : July 2, 2019
Estimated Primary Completion Date : December 2, 2019
Estimated Study Completion Date : December 2, 2020

Resource links provided by the National Library of Medicine


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 Name: Avenova




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 min 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018482


Contacts
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Contact: Gabriel Gordon, PhD 805-963-1648 ext 3028 gabe@californiaretina.com
Contact: Robert Avery, MD 805-963-1648 bobave@gmail.com

Sponsors and Collaborators
California Retina Consultants
Investigators
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Principal Investigator: Robert Avery, MD California Retina Consultants

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Responsible Party: Robert Avery, Principal Investigator, California Retina Consultants
ClinicalTrials.gov Identifier: NCT04018482     History of Changes
Other Study ID Numbers: PAVE study
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: we do not plan to share IPD with other researchers.

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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
Keywords provided by Robert Avery, California Retina Consultants:
intravitreal
injection
disinfectant
comfort
Povidone Iodine
Avenova
Additional relevant MeSH terms:
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Macular Degeneration
Macular Edema
Diabetic Retinopathy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Iodine
Cadexomer iodine
Povidone-Iodine
Disinfectants
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes