Effectiveness of Upper Punctal Plug Occlusion in Patients With Dry Eye Disease With Previous Lower Punctal Occlusion.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. Effectiveness
研究概览
简要总结
This study evaluates the therapeutic effect of upper punctal plug occlusion in patients with dry eye disease with previous lower punctal occlusion.
详细描述
This prospective, consecutive, interventional, longitudinal, case series study includes patients with aqueous-deficient dry eye disease who have inferior punctal occlusion. The study aims to evaluate the effect of superior lacrimal punctal occlusion with a plug dry eye symptoms and signs. Assessments will be performed at baseline and at 2 weeks, 4 weeks, 3 months, and 6 months following superior punctal occlusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Patients of both sexes
- •One or both eyes may be included
- •Inferior lacrimal punctum occluded (with a punctal plug or cauterization), clinically sealed under slit-lamp examination
- •Functional superior lacrimal punctum
- •Aqueous-deficient dry eye (such as Sjögren's disease, graft-versus-host disease, or primary dry eye disease.)
- •Age >18 years
- •OSDI score >13 and one of the following signs: Tear film markers (Fluorescein tear break up-time <5, First non-invasive tear breakup time <10, Schirmer test without anesthesia <10 mm, Schirmer test with anesthesia <10 mm), Ocular surface markers (corneal staining >5 spots or conjunctival staining >9 spots).
排除标准
- •Active ocular surface infection.
- •Patients who are unwilling to participate or to provide written informed consent.
研究组 & 干预措施
1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who
1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum.
干预措施: Punctal plug occlusion (Procedure)
结局指标
主要结局
1. Effectiveness
时间窗: Baseline, 2 weeks, 4 weeks, 3 months and 6 months
To evaluate signs and symptoms of dry eye, after superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum at baseline, 2 weeks, 4 weeks, 3 months and 6 months
次要结局
- Change in lower tear meniscus heigh(Baseline to 3 months after upper punctal plug placement.)
- Change in lower tear meniscus area(Baseline to 3 months after upper punctal plug placement.)
- Change from baseline in dry eye severity as assessed by the Ocular Surface Disease Index (OSDI)(Baseline to 3 months after upper punctal plug placement.)
- Change from baseline in dry eye symptoms as assessed by the Symptom Assessment in Dry Eye (SANDE) scale.(Baseline to 3 months after upper punctal plug placement.)
- Change in tear film break-up time (TFBUT).(Baseline to 3 months after upper punctal plug placement.)
- Change in non-invasive tear break-up time (NIBUT).(Baseline to 3 months after upper punctal plug placement.)
- Upper punctal plug retention rate.(Up to 3 months after upper punctal plug placement.)
- Change from baseline in ocular surface damage as assessed by the SICCA Ocular Surface Staining Score (OSS).(Baseline to 3 months after upper punctal plug placement.)
- Change from baseline in corneal epithelial damage as assessed by the National Eye Institute Corneal Fluorescein Staining (NEI) score(Baseline to 3 months after upper punctal plug placement.)
- Change in Schirmer I test results.(Baseline to 3 months after upper punctal plug placement.)
- Change in corneal sensitivity.(Baseline to 3 months after upper punctal plug placement.)
- Incidence of epiphora after upper punctal plug placement.(Up to 3 months after upper punctal plug placement.)
研究者
Karim Mohamed-Noriega
Principal Investigator
Universidad Autonoma de Nuevo Leon