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| Name | Class |
|---|---|
| Nanodropper, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric Participant's Eyes Using Standard Pupilary Dilation | Active Comparator | Consenting pediatric participants will undergo standard pupillary dilation in one eye. |
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| Pediatric Participant's Eyes using Nanodropper attachment | Experimental | Consenting pediatric participants will undergo pupillary dilation in the second eye using the Nanodropper attachment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanodropper | Device | Device used for administering eye drops |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | Before and 30 minutes after dilation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before and 30 minutes After Dilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julius Oatts, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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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.
| ID | Title | Description |
|---|---|---|
| FG000 | Eyes Recieving Eye Drops From Standard of Care | Each participant was randomized to receive eye drops using the standard of care dropper in one of their eyes |
| FG001 | Eyes Recieving Eye Drops Using Nanodropper Device | Each participant was randomized to receive eye drops using the Nanodropper adaptor in one of their eyes. The Nanodropper device is an eye drop adaptor that administers a smaller quantity (10.4 ml) of eye drops |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline characteristics were determined for participants who enrolled in the study and cooperated with all measurements.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants received eye drops from the Nanodropper in one eye only and Standard of Care in the other eye. | Posted | Mean | 95% Confidence Interval | Diopters | Before dilation and 30 minutes after dilation | Eye | Eye |
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Adverse event data were collected during the time of the participant visit. Each participant visit lasted on average 1 hour.
Study staff monitored participants for adverse effects including transient seizure, psychosis, subjective fever, and subjective tachycardia.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eyes Recieving Eye Drops From Standard of Care | Each participant was randomized to receive eye drops using the standard of care dropper in one of their eyes |
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We chose a noninferiority margin of a loss of 10% of the treatment effect, which is more conservative than the 50% margin that has been recommended for some industry trials by the United States Food and Drug Administration. Study staff and participants were not masked to the intervention. Additionally, this cohort comprised predominantly children with dark irides but could limit the generalizability of these results. We did not measure minimizing systemic side effects and local irritation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julius Oatts, MD | University of California, San Francisco | (415) 353-2800 | Julius.Oatts@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2022 | Jun 25, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2020 | Jun 25, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard Eye Dropper | Device | Standard Eye Dropper used for administering eye drops |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Each participant was randomized to receive eye drops using the Nanodropper adaptor in one of their eyes. The Nanodropper device is an eye drop adaptor that administers a smaller quantity (10.4 ml) of eye drops |
|
|
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| 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. | Participants received eye drops from the Nanodropper in one eye only and Standard of Care in the other eye. | Posted | Mean | 95% Confidence Interval | mm | Before dilation and 30 minutes after dilation | Eyes | Eyes |
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| Primary | Constriction Percentage | Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum | Participants received eye drops from the Nanodropper in one eye only and Standard of Care in the other eye. | Posted | Mean | 95% Confidence Interval | percent change | Before and 30 minutes after dilation | Eyes | Eyes |
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| 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. | Posted | Mean | 95% Confidence Interval | mmHg | Before and 30 minutes After Dilation | eyes | eyes |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Eyes Recieving Eye Drops Using Nanodropper Device | Each participant was randomized to receive eye drops using the Nanodropper adaptor in one of their eyes. The Nanodropper device is an eye drop adaptor that administers a smaller quantity (10.4 ml) of eye drops | 0 | 50 | 0 | 50 | 0 | 50 |
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| Change Score |
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| Change Score |
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| Change Score |
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