Trial Outcomes & Findings for Efficacy of the Nanodropper Device on Pupillary Dilation (NCT NCT05274321)
NCT ID: NCT05274321
Last Updated: 2023-09-25
Results Overview
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.
COMPLETED
NA
50 participants
Before dilation and 30 minutes after dilation
2023-09-25
Participant Flow
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.
Unit of analysis: eyes
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
50 50
|
50 50
|
|
Overall Study
COMPLETED
|
50 50
|
50 50
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pediatric Participants
n=50 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
|
|---|---|
|
Age, Categorical
<=18 years
|
50 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=50 Participants
|
|
Age, Continuous
|
9 years
STANDARD_DEVIATION 3 • n=50 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Before dilation and 30 minutes after dilationPopulation: Participants received eye drops from the Nanodropper in one eye only and Standard of Care in the other eye.
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.
Outcome measures
| Measure |
Eyes Recieving Eye Drops From Standard of Care
n=50 Eye
Each participant was randomized to receive eye drops using the standard of care dropper in one of their eyes
|
Eyes Recieving Eye Drops Using Nanodropper Device
n=50 Eye
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
|
|---|---|---|
|
Spherical Equivalent
Before Dilation
|
-2.62 Diopters
Interval -3.59 to -1.65
|
-2.28 Diopters
Interval -3.17 to -1.39
|
|
Spherical Equivalent
After Dilation
|
-0.86 Diopters
Interval -1.75 to 0.03
|
-0.55 Diopters
Interval -1.43 to 0.34
|
|
Spherical Equivalent
Change Score
|
1.76 Diopters
Interval 1.11 to 2.41
|
1.73 Diopters
Interval 1.11 to 2.36
|
PRIMARY outcome
Timeframe: Before dilation and 30 minutes after dilationPopulation: Participants received eye drops from the Nanodropper in one eye only and Standard of Care in the other eye.
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.
Outcome measures
| Measure |
Eyes Recieving Eye Drops From Standard of Care
n=50 Eyes
Each participant was randomized to receive eye drops using the standard of care dropper in one of their eyes
|
Eyes Recieving Eye Drops Using Nanodropper Device
n=50 Eyes
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
|
|---|---|---|
|
Maximum Pupil Diameter
Before Dilation
|
5.95 mm
Interval 5.76 to 6.14
|
6.01 mm
Interval 5.8 to 6.22
|
|
Maximum Pupil Diameter
After Dilation
|
7.91 mm
Interval 7.72 to 8.1
|
7.81 mm
Interval 7.61 to 8.01
|
|
Maximum Pupil Diameter
Change Score
|
1.95 mm
Interval 1.77 to 2.13
|
1.77 mm
Interval 1.58 to 1.96
|
PRIMARY outcome
Timeframe: Before and 30 minutes after dilationPopulation: Participants received eye drops from the Nanodropper in one eye only and Standard of Care in the other eye.
Pupillary constriction percentage was calculated by the pupillometer in response to a 180-micro watt flash: (maximum - minimum) / maximum
Outcome measures
| Measure |
Eyes Recieving Eye Drops From Standard of Care
n=50 Eyes
Each participant was randomized to receive eye drops using the standard of care dropper in one of their eyes
|
Eyes Recieving Eye Drops Using Nanodropper Device
n=50 Eyes
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
|
|---|---|---|
|
Constriction Percentage
Before Dilation
|
30.44 percent change
Interval 28.95 to 31.93
|
31.07 percent change
Interval 29.53 to 32.61
|
|
Constriction Percentage
After Dilation
|
5.67 percent change
Interval 3.21 to 8.14
|
6.26 percent change
Interval 4.35 to 8.17
|
|
Constriction Percentage
Change Score
|
-24.76 percent change
Interval -27.53 to -22.0
|
-24.81 percent change
Interval -26.72 to -22.49
|
SECONDARY outcome
Timeframe: Before and 30 minutes After DilationIntraocular pressure is the pressure, or force, inside of your eyes. Specifically, it's a measurement of the fluid pressure in your aqueous humor.
Outcome measures
| Measure |
Eyes Recieving Eye Drops From Standard of Care
n=50 eyes
Each participant was randomized to receive eye drops using the standard of care dropper in one of their eyes
|
Eyes Recieving Eye Drops Using Nanodropper Device
n=50 eyes
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
|
|---|---|---|
|
Change in Intraocular Pressure
Before Dilation
|
17.36 mmHg
Interval 16.24 to 18.48
|
18.13 mmHg
Interval 17.11 to 19.16
|
|
Change in Intraocular Pressure
After Dilation
|
18.42 mmHg
Interval 17.31 to 19.53
|
17.96 mmHg
Interval 16.84 to 19.08
|
|
Change in Intraocular Pressure
Change Score
|
1.06 mmHg
Interval -0.08 to 2.2
|
-0.17 mmHg
Interval -1.28 to 0.93
|
Adverse Events
Eyes Recieving Eye Drops From Standard of Care
Eyes Recieving Eye Drops Using Nanodropper Device
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Julius Oatts, MD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place