An interventional study of Nanodropper and Standard eye drop bottle in Medication Delivery and Eye Drop Delivery, sponsored by Sutter Health. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Sutter Health · Not applicable, Interventional, and Other
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.
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.
37 studies on the registry are indexed under Mydriasis; 4 are open to participants now.
This study's enrollment of 54 is below the median of 61 across 35 interventional studies indexed under Mydriasis.
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Exclusion Criteria:
For each participant, one eye (left or right) is randomly selected to be dilated with the Nanodropper.
Device: Nanodropper
Fellow eye is dilated with the standard eye drop bottle
Device: Standard eye drop bottle
One eye is randomly selected to be dilated with the nanodropper
eye is dilated with the standard eye drop bottle
Pupil size (diameter)
Pupil diameter (mm)
Time frame: 30 minutes after dilation
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Jan 2022, 0 months.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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