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

Primary Purpose

Eye Drops Self-instillation

Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Eye Drop Guide technique
Routine self-instillation technique
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Drops Self-instillation focused on measuring eye drops self-instillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine, Siriraj Hospital, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Routine self-instillation technique

Eye Drop Guide technique

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

To compare the success rate of self-instillation eye drops between carefully instructed routine technique and the use of Eye Drop Guide.

Secondary Outcome Measures

1. To compare the total number of drops dispensed and time to instill drop between 2 groups.
2. To identify the factors that associated with failure of using the Eye Drop Guide.

Full Information

First Posted
October 8, 2012
Last Updated
October 10, 2012
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01704248
Brief Title
The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients
Official Title
The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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?
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Drops Self-instillation
Keywords
eye drops self-instillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine self-instillation technique
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Eye Drop Guide technique
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Eye Drop Guide technique
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Routine self-instillation technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
1. To compare the total number of drops dispensed and time to instill drop between 2 groups.
Time Frame
1 month
Title
2. To identify the factors that associated with failure of using the Eye Drop Guide.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darin Sakiyalak, MD
Phone
66204198033-4
Email
darin.sak@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darin Sakiyalak, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darin Sakiyalak, MD
Phone
6624198033-4
Email
darin.sak@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Darin Sakiyalak, MD

12. IPD Sharing Statement

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

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