Summary

Eligibility
for people ages 2 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Julius Oatts, MD
Headshot of Julius Oatts
Julius Oatts

Description

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.

Details

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.

Keywords

Dilation, Pupil Reaction Absent, Pupil Disorders, Mydriasis, Pathologic Dilatation, MydCombi Device, MydCombi Drug, MydCombi

Eligibility

You can join if…

Open to people ages 2 years and up

- Receiving pupillary dilation in both eyes as part of the participant's standard of care.

You CAN'T join if...

  • Pupillary or anterior segment abnormality
  • Participants with pre-existing health conditions that would prevent pupillary dilation.

Location

  • UCSF
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Julius Oatts, MD
    Dr. Julius Oatts is a pediatric ophthalmologist and a pediatric glaucoma specialist who specializes in the medical and surgical treatment of children with common eye diseases as well as glaucoma, a rare condition in children. His research focuses on the most accurate ways to measure eye pressure in children.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06366217
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated