Expired Study
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Columbus, Ohio 43210


Purpose:

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.


Study summary:

The purpose of the project is to determine if emmetropization can be enhanced in very farsighted babies. We will give them glasses with a partial correction, an amount that is less than their full degree of farsightedness but enough to put them in the zone of effective emmetropization. This 'boost' is meant to enable very farsighted babies to use their eyes in a normal way and emmetropize as normal infants. This partial correction would be given at 3 months of age for a period of up to 15 months. A program of visual engagement is also provided in order to encourage the normal development and use of accommodation. As changes in farsightedness occur, the power of the glasses will be reduced at follow up appointments to keep the farsightedness within the zone of effective emmetropization. Once an infant reaches a normal amount of farsightedness, the glasses would be discontinued.


Criteria:

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


NCT ID:

NCT00574717


Primary Contact:

Principal Investigator
Donald O. Mutti, OD, PhD
The Ohio State University College of Optometry


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43210
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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