Glaucoma, Glaucoma Suspect
Conditions
Keywords
glaucoma, randomized controlled trial, eye drops, instillation, compliance
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.
Interventions
OTHEREncouragement 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.
Sponsors
Oftalmologia Hospital Sotero del Rio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Chile
Contacts
Primary ContactMilitza Sanchez, COT
Outcome results
None listed