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

Eye Drops Self-instillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01704248
• Other study ID #: 440/2555 (EC4)
• Status: Recruiting
• Phase: Phase 4
• First received: October 8, 2012
• Last updated: October 10, 2012
• Start date: October 2012
• Est. completion date: April 2013

Study information

• Verified date: October 2012
• Source: Mahidol University
• Contact: Darin Sakiyalak, MD
• Phone: 66204198033-4
• Email: darin.sak[@]mahidol.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eye Drops Self-instillation

Intervention

Device:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the success rate of self-instillation eye drops between carefully instructed routine technique and the use of Eye Drop Guide.		1 month	Yes
Secondary	1. To compare the total number of drops dispensed and time to instill drop between 2 groups.		1 month	Yes
Secondary	2. To identify the factors that associated with failure of using the Eye Drop Guide.		1 month	Yes