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临床试验/NCT03945071
NCT03945071已完成不适用

The Effect of Punctal Plugs in Reducing Ocular Surface Irritation After Povidone-Iodine Preparation of Intravitreal Injection

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2019年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
Change in ocular (eye) discomfort

研究概览

简要总结

The aim of this study is to evaluate the effectiveness of punctal plugs in reducing ocular surface (eye surface) irritation after intravitreal injections prepared by povidone-iodine 5% solution.

详细描述

Intravitreal injection is a shot of medication into the eye. Many retinal diseases, such as diabetic retinopathy, neovascular age-related macular degeneration, and retinal vein occlusions require regular, periodic injections. Patients often reports eye surface irritation post intravitreal injection. One of the reasons for such discomfort is attributed to povidone-iodine solution used to clean the eye surface to reduce sight-threatening infections. Patients who already experience symptoms of dry eye are at increased risk of discomfort after povidone-iodine prepped intravitreal injections.

Povidone-iodine is known to be corrosive to the corneal epithelium and delay eye surface healing. Human tears contain proteins and chemicals that lubricate, heal, and protect the eye surface from infections and irritants. Adequate tear film therefore not only dilutes povidone-iodine, but also promotes corneal healing post povidone-iodine prepping.

The primary long-term objective of the present study is to investigate whether punctal plugs will reduce eye discomfort post intravitreal injections as reported by the Ocular Surface Disease Index (OSDI) and other relevant surveys. The secondary outcome is to describe any other risk and protective factors associated with eye surface discomfort after intravitreal injections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Investigator)

入排标准

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

入选标准

  • •Clinical diagnosis of age-related macula degeneration
  • •Clinical diagnosis of diabetic retinopathy
  • •Clinical diagnosis of retinal vein occlusion

排除标准

  • •Currently wearing punctal plugs
  • •History of punctal cautery,
  • •Active ocular infection
  • •History of ocular infection
  • •Eyelid trauma
  • •Eyelid surgery
  • •Graft versus host disease
  • •Thyroid eye disease.

研究组 & 干预措施

Puntal plug

Active Comparator

Subjects will receive temporary punctal plug after intravitreal injection

干预措施: Punctal plug (Device)

Non-Punctual plug

No Intervention

Subjects will not receive temporary punctal plug after intravitreal injection

结局指标

主要结局

Change in ocular (eye) discomfort

时间窗: From date of randomization until date of death from any cause, whichever came first, assessed up to 100 weeks

Measure participants' level of discomfort after punctal plugs using the Ocular Surface Disease Index (OSDI), which is a paper survey that participants fill out based on their symptoms and level of ocular discomfort (if any).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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