Efficacy of the Nanodropper Device on Pupillary Dilation

NCT05274321 | Completed Results FDA Device

• 1 other identifier: 20-32530-OBS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dilation

Outcome Measures

Primary Outcomes (3)

• 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.

  Before dilation and 30 minutes after dilation

• 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.

  Before dilation and 30 minutes after dilation

• Constriction Percentage

  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 Outcomes (1)

• Change in Intraocular Pressure

  Before and 30 minutes After Dilation

Study Arms (2)

Pediatric Participant's Eyes Using Standard Pupilary Dilation

ACTIVE COMPARATOR

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

Device: Standard Eye Dropper

Pediatric Participant's Eyes using Nanodropper attachment

EXPERIMENTAL

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

Device: Nanodropper

Interventions

Nanodropper DEVICE

Device used for administering eye drops

Pediatric Participant's Eyes using Nanodropper attachment

Standard Eye Dropper DEVICE

Standard Eye Dropper used for administering eye drops

Pediatric Participant's Eyes Using Standard Pupilary Dilation

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants under the age of 18 years old

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Nanodropper, Inc.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

We chose a noninferiority margin of a loss of 10% of the treatment effect, which is more conservative than the 50% margin that has been recommended for some industry trials by the United States Food and Drug Administration. Study staff and participants were not masked to the intervention. Additionally, this cohort comprised predominantly children with dark irides but could limit the generalizability of these results. We did not measure minimizing systemic side effects and local irritation.

Results Point of Contact

• Title: Julius Oatts, MD
• Organization: University of California, San Francisco

Julius.Oatts@ucsf.edu

(415) 353-2800

Study Officials

• Julius Oatts, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: July 29, 2021
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: September 25, 2023
• Results First Posted: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)