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The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients

2012年10月10日更新者：Mahidol University

The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients.

To investigate if the Eye Drop Guide more effective than carefully instructed routine technique for chronic glaucoma patients to self-instill eye drops.

And what factors are associated with the failure of self-instillation eye drops with the Eye Drop Guide?

研究概览

地位

未知

条件

Eye Drops Self-instillation

干预/治疗

详细说明

The participants are randomized into 2 groups. For group I; the participants will be instructed to use the Eye Drop Guide first while for group II; the participants will be instructed to use the routine self-instillation technique first. The instruction will be given to all participants by the same investigator. The participants are allowed to practice until confidence in the techniques to which they are assigned. The participants then are instructed to use only that technique to instill eye drops in both eyes every day and keep the diary to document the date, time of practice, and number of bottles use in each eye for practice at home. The investigators make a telephone visit at 1 week to remind the practice routine and the follow up schedule. The 2 week follow up will be scheduled to evaluate the self-instillation performance using the techniques to which they are assigned by the VDO recordings under the same setting as Day 1.

After VDO recordings the participants will be switched to receive the other technique with the same instruction as the other group. Allow the same period of practice in the hospital and at home. The investigators again will make a 1-week telephone visit and 2-week follow up after self-practice at home. At week 4 the VDO recordings of self-instillation performance will be taken again under the same setting as previous records.

研究类型

介入性

注册 (预期的)

阶段

第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

泰国
- - Bangkok、泰国、10700
    - 招聘中
    - Faculty of Medicine, Siriraj Hospital, Mahidol University
    - 接触：
      
      Darin Sakiyalak, MD
      
      电话号码：6624198033-4
      
      邮箱：darin.sak@mahidol.ac.th
    - 首席研究员：
      
      Darin Sakiyalak, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Have been diagnosed of chronic glaucoma for 3 months or longer
Age of 18 years or over
Self-administer eye drops regularly

Exclusion Criteria:

Perioperative patients
Patients who were blind from other diseases
Patients with ophthalmic conditions that affect the eye drop instillation e.g. nystagmus, ptosis, exophthalmos, enophthalmos, microphthalmos, symblepharon, restrictive ophthalmoplegia
Patients whose underlying conditions would affect the patient's adherence to the protocol e.g. dementia, psychosis, mental retardation, neurological conditions resulting in tremor or paralysis, rheumatoid arthritis, hand deformities
Patients who are allergic to artificial tears eye drop
Patients who are not able to return for the follow-up schedule

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：交叉作业
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
安慰剂比较：Routine self-instillation technique The participants first use the Routine self-instillation technique for two weeks and then switch to the Eye Drop Guide technique for another two weeks.	设备：Eye Drop Guide technique Wash the hands. Shake and then uncap the bottle. Hold the bottle between the thumb, index, and/or middle finger of the dominant hand. Use the lower lip of the cup to pull the lower lid down like what they normally do with the fingers. Then place the upper lip down to cover the whole orbital rim area. Tilt the head back if seated or standing. Insert the bottle in the device all the way. Hold the bottle gently. Look upward. Squeeze the bottle one drop at a time until feel one drop instilled into the eye. Close the eye 2-3 minutes. For the non-seeing eye (best-corrected visual acuity ≤ 20/400) the participants should insert the bottle in the device before cover the eye then proceed with head tilt and look upward.
实验性的：Eye Drop Guide technique The participants first use the Eye Drop Guide technique for two weeks and then switch to the Routine self-instillation technique for another two weeks.	行为的：Routine self-instillation technique Wash the hands. Shake and then uncap the bottle. Hold the bottle between the thumb, index, and/or middle finger of the dominant hand. Lie down or tilt the head back if seated or standing. Using the other hand, pull the lower lid down. Hold the bottle over the eye and look up. Squeeze the bottle one drop at a time until feel one drop instilled into the eye. Close the eye 2-3 minutes. For the participants using more than one medication after instilling one bottle the participants should wait 3-5 minutes between administering different medications in the same eye.

参与者组/臂

干预/治疗

安慰剂比较：Routine self-instillation technique

The participants first use the Routine self-instillation technique for two weeks and then switch to the Eye Drop Guide technique for another two weeks.

设备：Eye Drop Guide technique

Wash the hands.
Shake and then uncap the bottle.
Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.
Use the lower lip of the cup to pull the lower lid down like what they normally do with the fingers.
Then place the upper lip down to cover the whole orbital rim area.
Tilt the head back if seated or standing.
Insert the bottle in the device all the way. Hold the bottle gently.
Look upward.
Squeeze the bottle one drop at a time until feel one drop instilled into the eye.
Close the eye 2-3 minutes.

For the non-seeing eye (best-corrected visual acuity ≤ 20/400) the participants should insert the bottle in the device before cover the eye then proceed with head tilt and look upward.

实验性的：Eye Drop Guide technique

The participants first use the Eye Drop Guide technique for two weeks and then switch to the Routine self-instillation technique for another two weeks.

行为的：Routine self-instillation technique

Wash the hands.
Shake and then uncap the bottle.
Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.
Lie down or tilt the head back if seated or standing.
Using the other hand, pull the lower lid down.
Hold the bottle over the eye and look up.
Squeeze the bottle one drop at a time until feel one drop instilled into the eye.
Close the eye 2-3 minutes.

For the participants using more than one medication after instilling one bottle the participants should wait 3-5 minutes between administering different medications in the same eye.

研究衡量的是什么？

主要结果指标

结果测量	大体时间
To compare the success rate of self-instillation eye drops between carefully instructed routine technique and the use of Eye Drop Guide. 大体时间：1 month	1 month

次要结果测量

结果测量	大体时间
1. To compare the total number of drops dispensed and time to instill drop between 2 groups. 大体时间：1 month	1 month
2. To identify the factors that associated with failure of using the Eye Drop Guide. 大体时间：1 month	1 month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Mahidol University

调查人员

首席研究员：Darin Sakiyalak, MD、Mahidol university

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年10月1日

初级完成 (预期的)

2013年2月1日

研究完成 (预期的)

2013年4月1日

研究注册日期

首次提交

2012年10月8日

首先提交符合 QC 标准的

2012年10月10日

首次发布 (估计)

2012年10月11日

研究记录更新

最后更新发布 (估计)

2012年10月11日

上次提交的符合 QC 标准的更新

2012年10月10日

最后验证

2012年10月1日

The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients