Dilation
Conditions
Brief 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.
Interventions
DEVICENanodropper
Device used for administering eye drops
DEVICEStandard Eye Dropper
Standard Eye Dropper used for administering eye drops
Sponsors
Nanodropper, Inc.
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spherical Equivalent | Before dilation and 30 minutes after dilation | 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. |
| Maximum Pupil Diameter | Before dilation and 30 minutes after dilation | 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. |
| Constriction Percentage | Before and 30 minutes after dilation | Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure | Before and 30 minutes After Dilation | Intraocular pressure is the pressure, or force, inside of your eyes. Specifically, it's a measurement of the fluid pressure in your aqueous humor. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Pediatric Participants Consenting participants will undergo standard pupillary dilation in one eye and pupillary dilation in the second eye using the Nanodropper attachment.
Nanodropper: Device used for administering eye drops | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Pediatric Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 50 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Age, Continuous | 9 years STANDARD_DEVIATION 3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 50 Participants | — |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 29 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
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
Population: Participants received eye drops from the Nanodropper in one eye only and Standard of Care in the other eye.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Eyes Recieving Eye Drops From Standard of Care | Constriction Percentage | Before Dilation | 30.44 percent change |
| Eyes Recieving Eye Drops From Standard of Care | Constriction Percentage | After Dilation | 5.67 percent change |
| Eyes Recieving Eye Drops From Standard of Care | Constriction Percentage | Change Score | -24.76 percent change |
| Eyes Recieving Eye Drops Using Nanodropper Device | Constriction Percentage | Before Dilation | 31.07 percent change |
| Eyes Recieving Eye Drops Using Nanodropper Device | Constriction Percentage | After Dilation | 6.26 percent change |
| Eyes Recieving Eye Drops Using Nanodropper Device | Constriction Percentage | Change Score | -24.81 percent change |
Comparison: Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.p-value: 0.03Regression, Linear
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.
Time frame: Before dilation and 30 minutes after dilation
Population: Participants received eye drops from the Nanodropper in one eye only and Standard of Care in the other eye.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Eyes Recieving Eye Drops From Standard of Care | Maximum Pupil Diameter | Before Dilation | 5.95 mm |
| Eyes Recieving Eye Drops From Standard of Care | Maximum Pupil Diameter | After Dilation | 7.91 mm |
| Eyes Recieving Eye Drops From Standard of Care | Maximum Pupil Diameter | Change Score | 1.95 mm |
| Eyes Recieving Eye Drops Using Nanodropper Device | Maximum Pupil Diameter | Before Dilation | 6.01 mm |
| Eyes Recieving Eye Drops Using Nanodropper Device | Maximum Pupil Diameter | After Dilation | 7.81 mm |
| Eyes Recieving Eye Drops Using Nanodropper Device | Maximum Pupil Diameter | Change Score | 1.77 mm |
Comparison: Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.p-value: 0.02Regression, Linear
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.
Time frame: Before dilation and 30 minutes after dilation
Population: Participants received eye drops from the Nanodropper in one eye only and Standard of Care in the other eye.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Eyes Recieving Eye Drops From Standard of Care | Spherical Equivalent | Before Dilation | -2.62 Diopters |
| Eyes Recieving Eye Drops From Standard of Care | Spherical Equivalent | After Dilation | -0.86 Diopters |
| Eyes Recieving Eye Drops From Standard of Care | Spherical Equivalent | Change Score | 1.76 Diopters |
| Eyes Recieving Eye Drops Using Nanodropper Device | Spherical Equivalent | Before Dilation | -2.28 Diopters |
| Eyes Recieving Eye Drops Using Nanodropper Device | Spherical Equivalent | After Dilation | -0.55 Diopters |
| Eyes Recieving Eye Drops Using Nanodropper Device | Spherical Equivalent | Change Score | 1.73 Diopters |
Comparison: Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.p-value: 0.22Regression, Linear
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.
Time frame: Before and 30 minutes After Dilation
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Eyes Recieving Eye Drops From Standard of Care | Change in Intraocular Pressure | Before Dilation | 17.36 mmHg |
| Eyes Recieving Eye Drops From Standard of Care | Change in Intraocular Pressure | After Dilation | 18.42 mmHg |
| Eyes Recieving Eye Drops From Standard of Care | Change in Intraocular Pressure | Change Score | 1.06 mmHg |
| Eyes Recieving Eye Drops Using Nanodropper Device | Change in Intraocular Pressure | Change Score | -0.17 mmHg |
| Eyes Recieving Eye Drops Using Nanodropper Device | Change in Intraocular Pressure | Before Dilation | 18.13 mmHg |
| Eyes Recieving Eye Drops Using Nanodropper Device | Change in Intraocular Pressure | After Dilation | 17.96 mmHg |
Comparison: Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.p-value: 0.25Regression, Linear