Efficacy of the Nanodropper Device on Pupillary Dilation

September 21, 2023 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Study Population

Any child age 2-17 years old undergoing a routine dilated eye examination at University of California, San Francisco (UCSF) for one visit

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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
Consenting pediatric participants will undergo standard pupillary dilation in one eye.
Device: Standard Eye Dropper
Standard Eye Dropper used for administering eye drops
Experimental: Pediatric Participant's Eyes using Nanodropper attachment
Consenting pediatric participants will undergo pupillary dilation in the second eye using the Nanodropper attachment.
Device: Nanodropper
Device used for administering eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before dilation and 30 minutes after dilation
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.
Before dilation and 30 minutes after dilation
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
Before and 30 minutes after dilation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before and 30 minutes After Dilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Nanodropper, Inc.

Investigators

  • Principal Investigator: Julius Oatts, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2021

Primary Completion (Actual)

November 19, 2021

Study Completion (Actual)

November 19, 2021

Study Registration Dates

First Submitted

March 1, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-32530-OBS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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