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出境医 / 临床实验 / Povidone Iodine vs AVEnova: A Pre-injection Disinfection Study (PAVE Study) (PAVE)

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

Study Description
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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
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)
Actual Study Start Date : July 16, 2019
Actual Primary Completion Date : August 14, 2019
Actual Study Completion Date : August 14, 2019
Arms and Interventions
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
Outcome Measures
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 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.


Eligibility Criteria
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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.
Contacts and Locations

Locations
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United States, California
California Retina Consultants
Santa Barbara, California, United States, 93103
Sponsors and Collaborators
California Retina Consultants
Investigators
Layout table for investigator information
Principal Investigator: Robert Avery, MD California Retina Consultants
Tracking Information
First Submitted Date  ICMJE July 5, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE July 16, 2019
Actual Primary Completion Date August 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2020) 		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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019) 		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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Povidone Iodine vs AVEnova: A Pre-injection Disinfection Study (PAVE Study)
Official Title  ICMJE Povidone Iodine vs AVEnova: A Pre-injection Disinfection Study (PAVE Study)
Brief Summary To compare the efficacy and comfort of two FDA approved pre-injection antiseptics when used for intravitreal injections.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE
  • Age-related Macular Degeneration
  • Diabetic Retinopathy
  • Diabetic Macular Edema
Intervention  ICMJE
  • Other: Povidone Iodine
    FDA-approved disinfectant for intravitreal injections
  • Other: Hypochlorous Acid
    FDA-approved disinfectant for intravitreal injections
    Other Name: Avenova
Study Arms  ICMJE 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.
Interventions:
  • Other: Povidone Iodine
  • Other: Hypochlorous Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 14, 2019
Actual Primary Completion Date August 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04018482
Other Study ID Numbers  ICMJE PAVE study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: we do not plan to share IPD with other researchers.
Responsible Party Robert Avery, California Retina Consultants
Study Sponsor  ICMJE California Retina Consultants
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Avery, MD California Retina Consultants
PRS Account California Retina Consultants
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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