Glaucoma Clinical Trial
Official title:
Eyedrop Instillation Technique: A Randomizaed Controlled Trial
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.
Status | Recruiting |
Enrollment | 230 |
Est. completion date | March 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Chile | Hospital Sotero del Rio | Santiago | RM |
Lead Sponsor | Collaborator |
---|---|
Oftalmologia Hospital Sotero del Rio |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete success | 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. |
Day 1. Immediately after intervention. | No |
Secondary | Qualified success | 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. |
Day 1. Same day as intervention. | No |
Secondary | Number of drops | 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. |
Day 1. | No |
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