TerminatedPhase 1/2

Enhancement of Emmetropization in Hyperopic Infants

Stopped: Lack of funding support for continued recruitment, enrollment, treatment

United States6 participantsStarted 2007-12

Plain-language summary

To determine if wearing a moderate spectacle under-correction (3.00D) and performing activities designed to stimulate accurate accommodation during a 15-month period will enhance emmetropization in highly hyperopic (between +5.00D and +7.00D) 3-month old infants.

Who can participate

Age range8 Weeks – 20 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 3 months of age (between 8 weeks and 20 weeks)at the baseline examination * Either gender, any ethnicity * Birthweight greater than 2500g * Normal pregnancy and delivery (including Cesarean section delivery but excluding serious complications or conditions such as eclampsia or rubella) * Hyperopia of +5.00D or more but less than +7.00D spherical equivalent refractive error in each eye by cycloplegic retinoscopy using cyclopentolate 1% * Currently under the care of a pediatrician Exclusion Criteria: * Anisometropia greater than 1.00D (difference in spherical equivalent) * Strabismus * Previous history of difficulty with pupillary dilation * History of cardiac, liver, asthma, or other respiratory disease * History of ocular disease or active ocular inflammation

What they're measuring

The primary outcome will be to determine if the criterion level for emmetropization (≤+3.00D by 18 months of age) is met and maintained by at least 70% of treated infants.

Timeframe: 15 months

Trial details

NCT IDNCT00574717

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-09

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