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临床试验/NCT04633798
NCT04633798Unknown不适用

Evaluation of the Efficacy of Intense Pulse Light Combined With Lipiflow in the Treatment of Meibomian Gland Dysfunction

Aier School of Ophthalmology, Central South University0 个研究点目标入组 100 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Breakup time

研究概览

简要总结

To compare the effect of IPL combined with lipiflow and IPL combined with meibomian gland massage in treating meibomian gland dysfunction of different degrees ,focusing on effective rate, lasting time and changes of meibomian gland function and morphology.

详细描述

To divide all participants into two groups, group one treated with IPL combined with Lipiflow and group two treated with IPL combined with meibomian gland massage.The following parameters were recorded after treatment: the effective rate, lasting time and changes of meibomian gland function and morphology.All parameters were compared between the two groups.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with meibomian gland dysfunction
  • patients with ocular discomfort
  • skin type:FitzpatricⅠ-Ⅳ

排除标准

  • patients with acute ocular inflammation
  • eye surgery history in the last 12 months
  • patients who have received IPL or Lipiflow in the last 12 months
  • patients who wear contact lens in last one month

结局指标

主要结局

Breakup time

时间窗: 6 months

the shorter time, the poorer of the tear film stability

ocular surface disease index(OSDI)

时间窗: 6 months

The OSDI is assessed on a scale of 0 to 100,with higher scores representing greater disability

meibomian gland expressibility score and meibum quality score

时间窗: 6 months

The score is on a scale of 0 to 6.The higher scores, the severity of the meibomian gland function(the highest score is 6 and the lowest score is 0)

meibomian gland dropout score

时间窗: 6 months

the higher scores, the severity of the meibomian gland morphology(The highest score is 6 and the lowest score is 0)

次要结局

未报告次要终点

研究者

发起方
Aier School of Ophthalmology, Central South University
申办方类型
Other
责任方
Sponsor

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