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临床试验/NCT06120894
NCT06120894已完成不适用

Strip Meniscometry in Dry Eye Evaluation in Connection With Cataract Surgery

University Hospital Olomouc1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2021年11月1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
21
试验地点
1
主要终点
Change in strip meniscometry.

研究概览

简要总结

Strip meniscometry is a relatively new method for evaluating the tear meniscus. The aim of the study is to evaluate the possible effect of cataract surgery on ocular surface disease and to assess the possible benefit of strip meniscometry in the preoperative and postoperative evaluation of patients.

详细描述

Cataract surgery is one of the most successful anterior segment surgeries and usually results in excellent postoperative visual acuity. However, some patients may experience symptoms of dry eye disease after a successful procedure, most commonly a foreign body sensation in the eye, intermittent pain, and blurred vision. These problems then interfere with normal daily activities and also reduce the patient's satisfaction with the surgery.

The new method for tear film examination Strip meniscometry (SM) appears to be a suitable alternative to the Schirmer test. SM values correlate with Oxford score (fluorescein staining), tear break up time test or measurement of meniscus height using anterior segment optical coherence tomography. It is a minimally invasive and rapid examination method that measures the volume of the aqueous component of the tear film.

The aim of this study is to evaluate the possible influence of cataract surgery on the development of iatrogenic OSD and to assess the contribution of a new diagnostic method, SM, for the evaluation of OSD before and after cataract surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • age over 18 years
  • performing of pre-operative examination before cataract surgery
  • signed informed consent

排除标准

  • use of antiglaucoma drugs
  • chronic blepharitis
  • previous viral keratitis
  • previous keratoplasty or laser refractive surgery
  • known systemic disease causing changes on ocular surface (diabetes mellitus, connective tissue disease)
  • use of medication causing changes on ocular surface (antidepressant, beta blockers)

结局指标

主要结局

Change in strip meniscometry.

时间窗: Week 1, 4, 12

Strip Meniscometry Tube in millimeters.

次要结局

  • Change in lid-parallel conjunctival folds evaluation.(Week 1, 4, 12)
  • Change in ocular surface fluorescein staining.(Week 1, 4, 12)
  • Change in Ocular Surface Disease Index.(Week 1, 4, 12)
  • Change in tear film stability.(Week 1, 4, 12)

研究者

发起方
University Hospital Olomouc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zuzana Schreiberova

Principal Investigator

University Hospital Olomouc

研究点 (1)

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