The Retention Rate Between Superflex Punctal Plugs, and Parasol Punctal Occluders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Length of Retention
研究概览
简要总结
The purpose of this study is to determine if Parasol punctal occluders (Brand A) have a higher rate of retention than Superflex punctal plugs (Brand B).
详细描述
Eyes will be randomized to either Brand A or Brand B punctal plug. The primary outcome measure is length of time punctual plugs are retained, measured in months. This will be measured at monthly assessments for 6 months. Secondary outcome measures include patient satisfaction, and improvement in subjective and objective dry eye scores, as well as complications related to punctual plugs including spontaneous plug loss, and intolerance. We will evaluate these measures by repeating the Canadian Dry Eye Assessment, Schirmer 1, tear meniscus height, fluorescein corneal staining (NEI scale), and lissamine green conjunctival staining (NEI scale) at month 1, month 3, and month 6 visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate dry eye, severe dry eye
排除标准
- •silicone allergy, punctal stenosis, punctal occlusion, punctal cautery
结局指标
主要结局
Length of Retention
时间窗: 6 months
次要结局
- National Eye Institute Grading for Conjunctival Staining(6 months)
- National Eye Institute Corneal Fluorescein Staining Pattern(6 months)
- Canadian Dry Eye Assessment Score(6 months)
- Tear Meniscus Height(6 months)
研究者
Dr. Stephanie Baxter
Program Director Department of Ophthalmology
Queen's University