Age-related Macular Degeneration, Diabetic Retinopathy, Diabetic Macular Edema
Conditions
Keywords
intravitreal, injection, disinfectant, comfort, Povidone Iodine, Avenova
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.
Interventions
OTHERPovidone Iodine
FDA-approved disinfectant for intravitreal injections
OTHERHypochlorous Acid
FDA-approved disinfectant for intravitreal injections
Sponsors
California Retina Consultants
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A single cohort will have one eye (right) treated with Povidone Iodine (PI), and one eye (left) treated with Avenova.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
United States
Outcome results
None listed