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临床试验/NCT06158984
NCT06158984已完成不适用

Managing Dry Eye in Patients Using Glaucoma Drops

He Eye Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Non-invasive tear break-up time

研究概览

简要总结

A single center randomized controlled trial on managing dry eye signs and symptoms in patients using anti-glaucoma eye drops.

详细描述

To compare the safety and efficacy of IPL therapy on drug-induced dry eye caused by long-term use of anti glaucoma drugs;

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Masked examiner for all clinical assessments will not involved in the data collection or group allocation procedure for this research. The investigator will not be aware of the two groups.

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Able and willing to comply with the treatment/follow-up schedule
  • Bilateral signs and symptoms of dry eye disease

排除标准

  • Participants with systemic immune-mediated illnesses, such as secondary Sjögren's syndrome or graft-versus-host disease
  • Patients using topical medication(s) for the treatment of ocular disorders such as allergic conjunctivitis were excluded from the study.
  • Previous ocular surgery or trauma
  • 1-month history of blepharal and periorbital skin disease or allergies
  • Severe dry eyes with corneal epithelial defect
  • Limbic keratitis
  • Pterygium
  • Corneal neovascularization
  • Breastfeeding
  • Rheumatic immune systemic diseases
  • Herpes zoster infection
  • Pregnant women
  • Allergic to fluorescein
  • Contact lens wearers

结局指标

主要结局

Non-invasive tear break-up time

时间窗: Day-0 (baseline), 2-week, 4-weeks

Changes in non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.

次要结局

  • Quality of meibum grade(Day-0 (baseline), 2-week, 4-weeks)
  • Conjunctival hyperemia (RS score)(Day-0 (baseline), 2-week, 4-weeks)
  • Expressibility of meibum grade(Day-0 (baseline), 2-week, 4-weeks)
  • Conjunctivocorneal epithelial staining grade(Day-0 (baseline), 1-week, 2-weeks)
  • Tear Film Lipid Layer(Day-0 (baseline), 2-week, 4-weeks)
  • OSDI Score(Day-0 (baseline), 2-week, 4-weeks)

研究者

发起方
He Eye Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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