The Effect of Eyedrop Size on Pupillary Dilation Using the Nanodropper Bottle Adapter

NCT06689904 | Completed FDA Device

• 1 other identifier: 1826733-1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The average drop size produced by standard eyedrop bottle exceeds the maximal capacity that the human eye are absorb topically. This excess leads to medication waste, increased costs, and greater risk of side effects. The Nanodropper is a commercially available, FDA listed eyedrop bottle adapter that delivers a smaller drop size. The investigators hypothesize the Nanodropper is noninferior to the standard eye drop bottle for pupil dilation. In this study, participants have one eye randomly chosen to be dilated with the Nanodropper and the fellow eye dilated with the standard bottle with a 50/50 mixture of tropicamide 1% and phenylephrine 2.5%. Pupil size before and after 30 minutes of dilation are measured with a pupillometer and compared between fellow eyes to see if there is a difference.

Conditions

Medication Delivery; Eye Drop Delivery

Keywords

eye drops; pupil dilation; eye drop bottle device; eye drop size

Outcome Measures

Primary Outcomes (1)

• Pupil size (diameter)

  Pupil diameter (mm)

  30 minutes after dilation

Study Arms (2)

Eye dilated with the nanodropper

EXPERIMENTAL

For each participant, one eye (left or right) is randomly selected to be dilated with the Nanodropper.

Device: Nanodropper

Eye dilated with the standard bottle

ACTIVE COMPARATOR

Fellow eye is dilated with the standard eye drop bottle

Device: Standard eye drop bottle

Interventions

Nanodropper DEVICE

One eye is randomly selected to be dilated with the nanodropper

Eye dilated with the nanodropper

Standard eye drop bottle DEVICE

eye is dilated with the standard eye drop bottle

Eye dilated with the standard bottle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18 years old
• scheduled for routine bilateral eye dilation

You may not qualify if:

• narrow angles
• allergies to phenylephrine or tropicamide
• concurrent use of any mydriatic agents (e.g., atropine, cyclopentolate, brimonidine)
• baseline anisocoria (\>1 mm)
• traumatic pupil,
• surgical pupil
• unilateral pseudoexfoliation.

Sponsors & Collaborators

• Sutter Health: lead

Study Sites (1)

Lions Eye Clinic

San Francisco, California, 94012, United States

Location

MeSH Terms

Conditions

Mydriasis

Condition Hierarchy (Ancestors)

Pupil Disorders; Eye Diseases

Study Design

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

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 15, 2024
• Study Start: January 4, 2022
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)