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Novel Treatment for Farsightedness

(EVA-II Trial)

AM
Overseen ByAnn M Morrison, OD, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

To determine if wearing a novel treatment during a 15-month period will enhance emmetropization in 4-month-old infants who have demonstrated poor ocular accommodation (eye focusing).

Are You a Good Fit for This Trial?

This trial is for 4-month-old infants who have trouble focusing their eyes (poor accommodation) and are farsighted. Other health or eye conditions may exclude participation.

Inclusion Criteria

Signed parental permission and HIPAA authorization and willingness to comply with study procedures
Good general health based on parent-provided history, normal pregnancy and delivery without serious complications, and birthweight >2500 g
Mean MEM accommodative lag >+1.25 D based on three measurements throughout the baseline examination
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Exclusion Criteria

Anisometropia >1.50 D spherical equivalent
Previous difficulty with pupil dilation
Hydrocephalus, Down syndrome, cerebral palsy, severe developmental delay, or seizure disorder
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What Are the Treatments Tested in This Trial?

Interventions

  • Experimental treatment arm

Trial Overview

Researchers are testing if a new treatment, worn by the infant over 15 months, can help improve normal eye development and focusing ability compared to usual care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Spectacles and At-Home TherapyExperimental Treatment1 Intervention
Group II: ObservationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

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