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OpenTrials
Completed

NCT Number: NCT05274321

Efficacy of the Nanodropper Device on Pupillary Dilation

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.

Completed

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Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nanodropper

Device

Device used for administering eye drops

Standard Eye Dropper

Device

Standard Eye Dropper used for administering eye drops

Primary outcomes

  1. Spherical Equivalent

    Time frame: 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.

  2. Maximum Pupil Diameter

    Time frame: 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.

  3. Constriction Percentage

    Time frame: 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

Secondary outcomes

  1. Change in Intraocular Pressure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Nanodropper, Inc.

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2022
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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