Eyedrop Instillation Technique: A Randomizaed Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 230
- Locations
- 2
- Primary Endpoint
- Complete success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Complete success
Time Frame: 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 Outcomes
- Qualified success(Day 1. Same day as intervention.)
- Number of drops(Day 1.)