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临床试验/NCT05319470
NCT05319470已完成不适用

Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives

Democritus University of Thrace1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Intraocular Pressure (IOP)

研究概览

简要总结

Primary objective of this study is to study the efficacy of travoprost without preservatives in the treatment of glaucoma patients and to monitor the ocular surface.

详细描述

This is a prospective study including patients visiting the outpatient glaucoma clinic of the University General Hospital of Alexandroupolis for their standard evaluation. Study population is already under treatment with a travoprost preparation without preservatives. They will be fully informed about the procedure and the purpose of the study and a written consent will be obtained. For every patient included in the study intraocular pressure will be measured using a Goldman applanation tonometer, according to the standard way of practice at our clinic. Also, Tear Break-Up-Time (BUT), conjunctival hyperemia grading and Schirmer testing will be used to assess the ocular surface state. Visual field tests and OCT RNFL measurements will also be obtained. The above measurements will be repeated 6 months after the initial examination.

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
35 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with glaucoma treated with travoprost without preservatives.

排除标准

  • Co-administration of another anti-glaucoma preparation with or without preservatives, Sjogren's syndrome, poor eyelid occlusion of any etiology.

结局指标

主要结局

Intraocular Pressure (IOP)

时间窗: 6 months

Intraocular pressure measurement in both eyes using the Goldman applanation tonometer.

Ocular Surface Disease

时间窗: 6 months

Tear breakup time (TBUT), conjuctival hyperemia scoring and Schirmer testing will be used to assess the ocular surface state of the study population.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Georgios Labiris

Professor (Associate) of Democritus University of Thrace

Democritus University of Thrace

研究点 (1)

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