Eyedrop Instillation Technique

Sponsor

Oftalmologia Hospital Sotero del Rio (Other)

Overall Status

Unknown status

CT.gov ID

NCT01417689

Collaborator

(none)

230

Enrollment

Location

Arms

Duration (Months)

32.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Eye drop instillation is a problem from glaucoma patients. Studies reveal that 30-50% of glaucoma patients have problems instilling their eyedrops. These problems include not hitting the eye, spending many drops to get a single successful instillation and bottle contamination.

The present study will evaluate the effect of encouraging patients to put their eyedrops using one of 2 techniques, randomly assigned, to determine which is more successful at instilling the eye drop into the eye while spending the least amount of drug.

In one of the techniques the patient instills the eye drop with their eyes open in the inferior cul de sac. In the other technique the patient instills the eye drop with the eyes closed near the inner canthal region.

Patients will be randomized to encouragement to use the drops with either of the techniques.

Encouragement will take place over a visit where they will be subjected to:

Baseline evaluation of eye drop instillation using their usual technique.
Short (2-5 minute) educational session session for the assigned technique.
Followup evaluation immediately after the educational session.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Glaucoma Suspect	Other: Encouragement to attempt eye drop instillation with a specific technique	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Eyedrop Instillation Technique: A Randomizaed Controlled Trial

Study Start Date :

Aug 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2011

Anticipated Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Open-eyes Patients in this arm are encourage to attempt eye drop instillation using the most commonly used technique that involves looking up, pulling inferior lid down and putting the drop in the inferior cul de sac.	Other: Encouragement to attempt eye drop instillation with a specific technique Encouragement to one of the 2 techniques (open eyes and closed eyes) is accomplished through a standardized educational session designed to take2-5 minutes.
Experimental: Closed-eyes Patients in this group are encouraged to attempt eye drop instillation with both eyes closed near the medial canthal region. After feeling contact with the drop on the skin the drop is expected to enter the eye when opening the eye and resuming blinking.	Other: Encouragement to attempt eye drop instillation with a specific technique Encouragement to one of the 2 techniques (open eyes and closed eyes) is accomplished through a standardized educational session designed to take2-5 minutes.

Arm

Intervention/Treatment

Active Comparator: Open-eyes

Patients in this arm are encourage to attempt eye drop instillation using the most commonly used technique that involves looking up, pulling inferior lid down and putting the drop in the inferior cul de sac.

Other: Encouragement to attempt eye drop instillation with a specific technique

Encouragement to one of the 2 techniques (open eyes and closed eyes) is accomplished through a standardized educational session designed to take2-5 minutes.

Experimental: Closed-eyes

Patients in this group are encouraged to attempt eye drop instillation with both eyes closed near the medial canthal region. After feeling contact with the drop on the skin the drop is expected to enter the eye when opening the eye and resuming blinking.

Other: Encouragement to attempt eye drop instillation with a specific technique

Encouragement to one of the 2 techniques (open eyes and closed eyes) is accomplished through a standardized educational session designed to take2-5 minutes.

Outcome Measures

Primary Outcome Measures

Complete success [Day 1. Immediately after intervention.]
Total success is defined as: Patient manages to instill one eyedrop into de eye spending only one eye drop. Difference in the proportion of patients achieving successful eye drop instillation in each of the 2 groups. For the main analysis the results of the first eye (Right or left randomly determined will be used) A mixed model with both eyes in the analysis will also be presented for sensitivity analysis.

Secondary Outcome Measures

Qualified success [Day 1. Same day as intervention.]
Qualified success is defined as: Patient manages to instill one eye drop into the eye regardless of the amount of drops spent. Difference in the proportion of patients achieving successful eye drop instillation in each of the 2 groups. For the main analysis the results of the first eye (Right or left randomly determined will be used) A mixed model with both eyes in the analysis will also be presented for sensitivity analysis.
Number of drops [Day 1.]
Number of eye drops spent on attempted instillation in the first eye (randomly assigned). The average number of drops spent on each of the groups will be compared. Mixed models with data from both eyes will also be presented for sensitivity analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Glaucoma or glaucoma suspect
Use of topical glaucoma medication in both eyes for at least 1 year prior to enrollment
VA of 20/60 or better with habitual correction in at least one eye

Exclusion Criteria:

Previous history of allergy to fluorescein
Received topical anesthesia for IOP measurement or other reason within the last 2 hours.
Rejects participation