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

Sutter Health

Status: Completed

Conditions: Medication Delivery; Eye Drop Delivery

Treatments: Device: Nanodropper; Device: Standard eye drop bottle

Study type: Interventional

Funder types: Other

Identifiers

NCT06689904

1826733-1

Details and patient eligibility

About

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.

Full description

Ophthalmic medications are available in eyedrop bottles that produce on average a drop size of about 40 uL, while the human eye can only hold about 7-10uL. This excess leads to medication waste, increased costs, and greater risk of side effects.

The Nanodropper is a commercially available, FDA listed (class 1 medical device, 510(k) exempt) eyedrop bottle adapter that delivers a smaller drop size of 10 uL. The investigators hypothesize the Nanodropper is noninferior to the standard eye drop bottle for pupil dilation.

This is a prospective comparative matched pairs study of adults scheduled for routine bilateral eye dilation. Exclusion criteria includes anisocoria and medications affecting pupil size. One eye is randomly 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 within the same subject with a noninferiority margin of 0.5mm.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Eye dilated with the nanodropper

Experimental group

Description:

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

Treatment:

Device: Nanodropper

Eye dilated with the standard bottle

Active Comparator group

Description:

Fellow eye is dilated with the standard eye drop bottle

Treatment:

Device: Standard eye drop bottle