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临床试验/NCT04018482
NCT04018482已完成4 期

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

California Retina Consultants2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年7月16日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
2
主要终点
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)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects must be receiving same day bilateral injections of an anti-VEGF agent for any ophthalmic condition.
  • Subject must be fluent in English.

排除标准

  • Under 18 years old.
  • Subjects with an allergy or adverse reaction to Povidone Iodine or Avenova.

结局指标

主要结局

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)

时间窗: 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.

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)

时间窗: 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.

次要结局

  • 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).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Avery

Principal Investigator

California Retina Consultants

研究点 (2)

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