Clinical trial NCT04018482: Povidone Iodine vs AVEnova: A Pre-injection Disinfection Study (PAVE Study)
Official title: Povidone Iodine vs AVEnova: A Pre-injection Disinfection Study (PAVE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age-related Macular Degeneration
Diabetic Retinopathy
Diabetic Macular Edema
Keywords: intravitreal
injection
disinfectant
comfort
Povidone Iodine
Avenova
Lead sponsor: California Retina Consultants
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single cohort will have one eye (right) treated with Povidone Iodine (PI), and one eye (left) treated with Avenova.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: Immediately following the subject's injection.
measure: 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)
timeFrame: 1-2 hours post-injection.
Secondary outcomes:
measure: 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.
timeFrame: 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).
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
Study officials:
affiliation: California Retina Consultants
name: Robert Avery, MD
role: PRINCIPAL_INVESTIGATOR
References: