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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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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
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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?


Condition or disease Intervention/treatment Phase
Eye Drops Self-instillation Device: Eye Drop Guide technique Behavioral: Routine self-instillation technique Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
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
  1. Wash the hands.
  2. Shake and then uncap the bottle.
  3. Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.
  4. Use the lower lip of the cup to pull the lower lid down like what they normally do with the fingers.
  5. Then place the upper lip down to cover the whole orbital rim area.
  6. Tilt the head back if seated or standing.
  7. Insert the bottle in the device all the way. Hold the bottle gently.
  8. Look upward.
  9. Squeeze the bottle one drop at a time until feel one drop instilled into the eye.
  10. 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.


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
  1. Wash the hands.
  2. Shake and then uncap the bottle.
  3. Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.
  4. Lie down or tilt the head back if seated or standing.
  5. Using the other hand, pull the lower lid down.
  6. Hold the bottle over the eye and look up.
  7. Squeeze the bottle one drop at a time until feel one drop instilled into the eye.
  8. 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 Measures :
  1. 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 Measures :
  1. 1. To compare the total number of drops dispensed and time to instill drop between 2 groups. [ Time Frame: 1 month ]
  2. 2. To identify the factors that associated with failure of using the Eye Drop Guide. [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Darin Sakiyalak, MD 66204198033-4 darin.sak@mahidol.ac.th

Locations
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Thailand
Faculty of Medicine, Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Darin Sakiyalak, MD    6624198033-4    darin.sak@mahidol.ac.th   
Principal Investigator: Darin Sakiyalak, MD         
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Darin Sakiyalak, MD Mahidol University

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01704248     History of Changes
Other Study ID Numbers: 440/2555 (EC4)
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012
Keywords provided by Mahidol University:
eye drops self-instillation
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions