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Efficacy of the Nanodropper Device on Pupillary Dilation

Primary Purpose

Dilation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nanodropper
Standard Eye Dropper
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dilation

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pediatric Participant's Eyes Using Standard Pupilary Dilation

Pediatric Participant's Eyes using Nanodropper attachment

Arm Description

Consenting pediatric participants will undergo standard pupillary dilation in one eye.

Consenting pediatric participants will undergo pupillary dilation in the second eye using the Nanodropper attachment.

Outcomes

Primary Outcome Measures

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.
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.
Constriction Percentage
Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum

Secondary Outcome Measures

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.

Full Information

First Posted
March 1, 2022
Last Updated
September 21, 2023
Sponsor
University of California, San Francisco
Collaborators
Nanodropper, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05274321
Brief Title
Efficacy of the Nanodropper Device on Pupillary Dilation
Official Title
Efficacy of the Nanodropper Device on Pupillary Dilation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 29, 2021 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
November 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Nanodropper, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pediatric Participant's Eyes Using Standard Pupilary Dilation
Arm Type
Active Comparator
Arm Description
Consenting pediatric participants will undergo standard pupillary dilation in one eye.
Arm Title
Pediatric Participant's Eyes using Nanodropper attachment
Arm Type
Experimental
Arm Description
Consenting pediatric participants will undergo pupillary dilation in the second eye using the Nanodropper attachment.
Intervention Type
Device
Intervention Name(s)
Nanodropper
Intervention Description
Device used for administering eye drops
Intervention Type
Device
Intervention Name(s)
Standard Eye Dropper
Intervention Description
Standard Eye Dropper used for administering eye drops
Primary Outcome Measure Information:
Title
Spherical Equivalent
Description
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.
Time Frame
Before dilation and 30 minutes after dilation
Title
Maximum Pupil Diameter
Description
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.
Time Frame
Before dilation and 30 minutes after dilation
Title
Constriction Percentage
Description
Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum
Time Frame
Before and 30 minutes after dilation
Secondary Outcome Measure Information:
Title
Change in Intraocular Pressure
Description
Intraocular pressure is the pressure, or force, inside of your eyes. Specifically, it's a measurement of the fluid pressure in your aqueous humor.
Time Frame
Before and 30 minutes After Dilation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julius Oatts, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of the Nanodropper Device on Pupillary Dilation

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