Metric-Optimized Spectacles for Children With Down Syndrome

HA
Overseen ByHeather Anderson, OD, PhD
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study seeks to determine whether glasses prescriptions determined from computer analysis of detailed images of the eyes provide better vision outcomes for children with Down syndrome than prescriptions determined using routine clinical methods.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 5 to 12 years old with Down syndrome and can sit and have my eyes dilated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Enrollment Exam

Participants undergo distance refraction measurement, pupil size measurement, and wavefront aberration measurement. A complete eye examination is performed.

1 day
1 visit (in-person)

Treatment

Participants receive spectacle prescriptions and undergo visual acuity and binocularity testing. Spectacles are dispensed in two-month intervals with a SmartButton data logger to assess wear time.

4 months
2 visits (in-person) at two-month intervals

Follow-up

Participants are monitored for visual acuity and binocularity improvements after 6 months of continued spectacle wear.

6 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Metric-Optimized Spectacle Prescriptions

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Metric-Optimized First, Clinical SecondExperimental Treatment2 Interventions
Group II: Clinical First, Metric-Optimized SecondExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

National Eye Institute (NEI)

Collaborator

Trials
572
Recruited
1,320,000+