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

Diabetic Retinopathy Clinical Trial

— PAVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018482
• Other study ID #: PAVE study
• Status: Completed
• Phase: Phase 4
• Start date: July 16, 2019
• Est. completion date: August 14, 2019

Study information

• Verified date: July 2019
• Source: California Retina Consultants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 14, 2019
• Est. primary completion date: August 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Diabetic Macular Edema
• Diabetic Retinopathy
• Macular Degeneration
• Macular Edema

Intervention

Other:
• Povidone Iodine
FDA-approved disinfectant for intravitreal injections
• Hypochlorous Acid
FDA-approved disinfectant for intravitreal injections

Locations

Country	Name	City	State
United States	California Retina Consultants	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
California Retina Consultants

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.
Primary	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)	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	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.	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).