NCT04018482

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: California Retina Consultants · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Povidone Iodine	FDA-approved disinfectant for intravitreal injections
OTHER	Hypochlorous Acid	FDA-approved disinfectant for intravitreal injections

Timeline

• Start date: 2019-07-16
• Primary completion: 2019-08-14
• Completion: 2019-08-14
• First posted: 2019-07-12
• Last updated: 2020-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study