Efficacy of the Nanodropper Device on Pupillary Dilation

Dilation Clinical Trial

Official title:

Efficacy of the Nanodropper Device on Pupillary Dilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05274321
• Other study ID #: 20-32530-OBS
• Status: Completed
• Phase: N/A
• Start date: July 29, 2021
• Est. completion date: November 19, 2021

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 19, 2021
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dilation
• Mydriasis

Intervention

Device:
• Nanodropper
Device used for administering eye drops
• Standard Eye Dropper
Standard Eye Dropper used for administering eye drops

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Nanodropper, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Before and 30 minutes After Dilation