Efficacy of the Nanodropper Device on Pupillary Dilation

NCT ID: NCT05274321

Last Updated: 2023-09-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-29

Study Completion Date

2021-11-19

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.

Detailed Description

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Conditions

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Dilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pediatric Participant's Eyes Using Standard Pupilary Dilation

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

Group Type ACTIVE_COMPARATOR

Standard Eye Dropper

Intervention Type DEVICE

Standard Eye Dropper used for administering eye drops

Pediatric Participant's Eyes using Nanodropper attachment

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

Group Type EXPERIMENTAL

Nanodropper

Intervention Type DEVICE

Device used for administering eye drops

Interventions

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Nanodropper

Device used for administering eye drops

Intervention Type DEVICE

Standard Eye Dropper

Standard Eye Dropper used for administering eye drops

Intervention Type DEVICE

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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanodropper, Inc.

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julius Oatts, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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20-32530-OBS

Identifier Type: -

Identifier Source: org_study_id

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