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

California Retina Consultants

Status and phase: Completed; Phase 4

Conditions: Diabetic Macular Edema; Age-related Macular Degeneration; Diabetic Retinopathy

Treatments: Other: Hypochlorous Acid; Other: Povidone Iodine

Study type: Interventional

Funder types: Other

Identifiers

NCT04018482

PAVE study

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Open label test arm

Experimental group

Description:

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.

Treatment:

Other: Povidone Iodine

Other: Hypochlorous Acid