Dilation, Pupil Reaction Absent
Conditions
Brief summary
To raise the standard of care, improve the overall patient experience and streamline practice flow, Eyenovia has developed an innovative mydriatic to be delivered as a microdose by a specialized dispenser. While still achieving effective pupil dilation, MydCombi has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery. The proposed study hopes to demonstrate the non-inferiority of using MydCombi to achieve pupillary dilation in patients compared to standard of care eye drops.
Detailed description
The proposed study strives to demonstrate the non-inferiority of using MydCombi to achieve pupillary dilation in patients compared to standard-of-care (SOC) eye drops in a randomized trial. Primary Aim: Demonstrate non-inferiority of using MydCombi to achieve pupillary dilation compared to standard-of-care eye drops in patients. Participants 2 years or older undergoing standard pupillary dilation will be randomized to use MydCombi in one eye and standard of care pupillary dilation in another eye.
Interventions
DEVICEMydCombi Device
ophthalmic spray
DRUGMydCombi Drug
Tropicamide 1% and phenylephrine HCl 2.5%
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Receiving pupillary dilation in both eyes as part of the participant's standard of care.
Exclusion criteria
* Pupillary or anterior segment abnormality * Participants with pre-existing health conditions that would prevent pupillary dilation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in 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. |
| Percent Change in 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 particpant's 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. |
| Percent Change in pupil 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 |
|---|---|---|
| Percent Change in Intraocular Pressure | Before and 30 minutes After Dilation | Intraocular pressure is the pressure, or force, inside of the participants eyes. Specifically, it's a measurement of the fluid pressure in the participant's aqueous humor. |
Countries
United States
Contacts
Primary ContactJulius Oatts, MD
Outcome results
None listed