An interventional study of Nanodropper and Standard Eye Dropper in Dilation, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
120 studies on the registry are indexed under Dilatation, Pathologic; 18 are open to participants now.
This study's enrollment of 50 is below the median of 82 across 84 interventional studies indexed under Dilatation, Pathologic.
Browse Dilatation, Pathologic studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Exclusion Criteria:
Consenting pediatric participants will undergo standard pupillary dilation in one eye.
Device: Standard Eye Dropper
Consenting pediatric participants will undergo pupillary dilation in the second eye using the Nanodropper attachment.
Device: Nanodropper
Device used for administering eye drops
Standard Eye Dropper used for administering eye drops
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.
Time frame: 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.
Time frame: 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
Time frame: Before and 30 minutes after dilation
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.
Time frame: Before and 30 minutes After Dilation
Children 18 years of age or younger undergoing pupillary dilation as part of a routine eye examination at the University of California, San Francisco, at the Pediatric Ophthalmology Clinic between August 4, 2021, and November 19, 2021 were assessed for eligibility. Children who did not show up to appointments or did not meet inclusion criteria were not enrolled in the study.
| Milestone | Eyes Recieving Eye Drops From Standard of Care | Eyes Recieving Eye Drops Using Nanodropper Device |
|---|---|---|
| Started | 50 | 50 |
| Completed | 50 | 50 |
| Not completed | 0 | 0 |
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.
| Diopters | Eyes Recieving Eye Drops From Standard of Care | Eyes Recieving Eye Drops Using Nanodropper Device |
|---|---|---|
| Before Dilation | -2.62 (-3.59 to -1.65) | -2.28 (-3.17 to -1.39) |
| After Dilation | -0.86 (-1.75 to 0.03) | -0.55 (-1.43 to 0.34) |
| Change Score | 1.76 (1.11 to 2.41) | 1.73 (1.11 to 2.36) |
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.
| mm | Eyes Recieving Eye Drops From Standard of Care | Eyes Recieving Eye Drops Using Nanodropper Device |
|---|---|---|
| Before Dilation | 5.95 (5.76 to 6.14) | 6.01 (5.80 to 6.22) |
| After Dilation | 7.91 (7.72 to 8.10) | 7.81 (7.61 to 8.01) |
| Change Score | 1.95 (1.77 to 2.13) | 1.77 (1.58 to 1.96) |
Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum
| percent change | Eyes Recieving Eye Drops From Standard of Care | Eyes Recieving Eye Drops Using Nanodropper Device |
|---|---|---|
| Before Dilation | 30.44 (28.95 to 31.93) | 31.07 (29.53 to 32.61) |
| After Dilation | 5.67 (3.21 to 8.14) | 6.26 (4.35 to 8.17) |
| Change Score | -24.76 (-27.53 to -22.00) | -24.81 (-26.72 to -22.49) |
Intraocular pressure is the pressure, or force, inside of your eyes. Specifically, it's a measurement of the fluid pressure in your aqueous humor.
| mmHg | Eyes Recieving Eye Drops From Standard of Care | Eyes Recieving Eye Drops Using Nanodropper Device |
|---|---|---|
| Before Dilation | 17.36 (16.24 to 18.48) | 18.13 (17.11 to 19.16) |
| After Dilation | 18.42 (17.31 to 19.53) | 17.96 (16.84 to 19.08) |
| Change Score | 1.06 (-0.08 to 2.20) | -0.17 (-1.28 to 0.93) |
Collected over Adverse event data were collected during the time of the participant visit. Each participant visit lasted on average 1 hour.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Eyes Recieving Eye Drops From Standard of Care | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Eyes Recieving Eye Drops Using Nanodropper Device | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
Baseline characteristics were determined for participants who enrolled in the study and cooperated with all measurements.
| Age, Categorical(Participants) | Pediatric Participants |
|---|---|
| <=18 years | 50 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Pediatric Participants |
|---|---|
| Mean | 9 ± 3 |
| Sex: Female, Male(Participants) | Pediatric Participants |
|---|---|
| Female | 21 |
| Male | 29 |
| Race and Ethnicity Not Collected(Participants) | Pediatric Participants |
|---|
| Region of Enrollment(Participants) | Pediatric Participants |
|---|---|
| United States | 50 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2021 to primary completion in Nov 2021, 3 months.
Results were first posted in Sep 2023, 1 year 10 months after primary completion.
Of 27 interventional studies with no phase under Dilatation, Pathologic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 3 months is below that.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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