Efficacy of the Nanodropper Device on Pupillary Dilation

Not Applicable

Completed

• Conditions: Dilation
• Interventions: Device: Nanodropper; Device: Standard Eye Dropper

• Registration Number: NCT05274321
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-07-29
• Primary Completion: 2021-11-19
• Study Completion: 2021-11-19
• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-10
• Results First Submitted: 2023-07-03
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-21
• Last Update Submitted: 2023-09-21
• Results First Posted: 2023-09-25
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Participants under the age of 18 years old

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Exclusion Criteria

• Participants 18 years and older
• Pupillary or anterior segment abnormality
• Participants with pre-existing health conditions that would prevent pupillary dilation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric Participant's Eyes using Nanodropper attachment	Nanodropper	Consenting pediatric participants will undergo pupillary dilation in the second eye using the Nanodropper attachment.
Pediatric Participant's Eyes Using Standard Pupilary Dilation	Standard Eye Dropper	Consenting pediatric participants will undergo standard pupillary dilation in one eye.

Primary Outcome Measures

Name	Time	Method
Constriction Percentage	Before and 30 minutes after dilation	Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum
Maximum Pupil Diameter	Before dilation and 30 minutes after dilation	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.
Spherical Equivalent	Before dilation and 30 minutes after dilation	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.

Secondary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure	Before and 30 minutes After Dilation	Intraocular pressure is the pressure, or force, inside of your eyes. Specifically, it's a measurement of the fluid pressure in your aqueous humor.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States