Efficacy of the Nanodropper Device on Pupillary Dilation

Study Overview
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Brief Summary
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Prescription eye drop bottles elute drops that exceed the capacity of the human eye by five times. This study describes performing in clinic dilation using a novel solution for combating medical waste with Nanodropper, an eye drop bottle adapter that creates smaller eye drops.

Official Title
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Efficacy of the Nanodropper Device on Pupillary Dilation

Conditions
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Dilation

Intervention / Treatment
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* Device: Nanodropper
* Device: Standard Eye Dropper


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants under the age of 18 years old Exclusion Criteria: Participants 18 years and older Pupillary or anterior segment abnormality Participants with pre-existing health conditions that would prevent pupillary dilation.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pediatric Participant's Eyes Using Standard Pupilary Dilation<br>Consenting pediatric participants will undergo standard pupillary dilation in one eye. | Device: Standard Eye Dropper<br>* Standard Eye Dropper used for administering eye drops<br>|
| Experimental: Pediatric Participant's Eyes using Nanodropper attachment<br>Consenting pediatric participants will undergo pupillary dilation in the second eye using the Nanodropper attachment. | Device: Nanodropper<br>* Device used for administering eye drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spherical Equivalent | Cycloplegia is the paralysis of the ciliary muscle of the eye resulting in dilatation of the pupil and paralysis of accommodation. Cycloplegia is defined as the change score. Change scores were calculated by subtracting the spherical equivalent value after dilation from the value before dilation for each eye. | Before dilation and 30 minutes after dilation | 
| Maximum Pupil Diameter | The pupil is the opening in the center of the iris (the structure that gives our eyes their color). The diameter is a straight line passing from side to side through the center of the pupil, which is shaped like a circle. | Before dilation and 30 minutes after dilation | 
| Constriction Percentage | Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum | Before and 30 minutes after dilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intraocular Pressure | Intraocular pressure is the pressure, or force, inside of your eyes. Specifically, it's a measurement of the fluid pressure in your aqueous humor. | Before and 30 minutes After Dilation |