The Effect of Punctal Plugs in Reducing Ocular Surface Irritation After Povidone-Iodine Preparation of Intravitreal Injection
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
Subjects will receive temporary punctal plug after intravitreal injection
干预措施: Punctal plug (Device)
Non-Punctual plug
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
