Corneal Diseases, Effectiveness of Microdrops
Conditions
Keywords
Corneal anesthesia, Nanodropper
Brief summary
The goal of this clinical trial is to compare the onset and duration of numbness of the surface of the eye following the administration of numbing drops, called proparacaine, using either a standard eye drop bottle or a "Nanodropper" adaptor. The Nanodropper is designed to administer smaller-sized drops, or microdrops. Participants will: 1. Complete a baseline eye exam. 2. Receive a numbing drop using a standard dropper in one eye and the Nanodropper in the other eye. 3. Have their eyes tested for numbness at specific time points (30 seconds, 1, 2, 5, and 10 minutes after getting the drops). 4. Tell the researchers if they feel pain during the eye sensation tests. 5. Complete a survey about their experience with the eyedrops and testing procedure. This study could help us find a way to use less medication while still effectively administering eye medications, potentially saving money and reducing medical waste.
Interventions
COMBINATION_PRODUCTNanodropper and Proparacaine HCl 0.5%
The Nanodropper is an eyedrop bottle adaptor that creates smaller eyedrops by coupling to an existing eyedrop bottle. This intervention involves the administration of proparacaine HCl 0.5% using the Nanodropper.
COMBINATION_PRODUCTStandard Eye Drop Bottle with Proparacaine HCl 0.5%
This intervention involves administration of proparacaine HCl 0.5% using a standard eye drop bottle.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Ability to provide informed consent for topical anesthesia delivery 2. Ability to verbally respond to pain 3. At least 18 years of age
Exclusion criteria
1. Have a contraindication to local anesthetics 2. History of intravitreal injections 3. History of ocular surgery 4. History of vitreous or retinal surgery 5. Preexisting diagnosis of ocular surface disease requiring punctal plug placement 6. Evidence of any current ocular inflammation 7. Any previous ocular condition (i.e., neurotrophic keratitis, herpetic eye disease, presence of a corneal graft, etc.) that has permanently altered the native sensation of the ocular surface 8. Use of contact lenses in the past 2 weeks 9. Use of exclusionary medications: Topical steroid drops, non-steroidal anti-inflammatory drops, intraocular pressure lowering eye drops, any anti-viral medications used for herpes, opioids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Anesthesia | 5 minutes | The primary outcome is the percent or proportion of subjects that achieve anesthesia at the 5-minute time point |
Countries
United States
Outcome results
None listed