The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients
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|ClinicalTrials.gov Identifier: NCT01704248|
Recruitment Status : Unknown
Verified October 2012 by Mahidol University.
Recruitment status was: Recruiting
First Posted : October 11, 2012
Last Update Posted : October 11, 2012
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?
|Condition or disease||Intervention/treatment||Phase|
|Eye Drops Self-instillation||Device: Eye Drop Guide technique Behavioral: Routine self-instillation technique||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients.|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||February 2013|
|Estimated Study Completion Date :||April 2013|
Placebo Comparator: 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.
Device: Eye Drop Guide technique
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.
Experimental: 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.
Behavioral: Routine self-instillation technique
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.
- To compare the success rate of self-instillation eye drops between carefully instructed routine technique and the use of Eye Drop Guide. [ Time Frame: 1 month ]
- 1. To compare the total number of drops dispensed and time to instill drop between 2 groups. [ Time Frame: 1 month ]
- 2. To identify the factors that associated with failure of using the Eye Drop Guide. [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704248
|Contact: Darin Sakiyalak, MDfirstname.lastname@example.org|
|Faculty of Medicine, Siriraj Hospital, Mahidol University||Recruiting|
|Bangkok, Thailand, 10700|
|Contact: Darin Sakiyalak, MD 6624198033-4 email@example.com|
|Principal Investigator: Darin Sakiyalak, MD|
|Principal Investigator:||Darin Sakiyalak, MD||Mahidol University|