Enhancement of Emmetropization in Hyperopic Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Enhancement of Emmetropization in Hyperopic Infants

Conditions
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Hypermetropia, Hyperopia, Farsightedness

Intervention / Treatment
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* Procedure: Spectacles


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Weeks
Maximum Age: 20 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Infants will receive spectacle under-correction of their hyperopia. | Procedure: Spectacles<br>* Infants will receive spectacles with 3.00D of under-correction relative to the spherical equivalent in each eye as measured by the cycloplegic retinoscopy performed at baseline. They will also receive the full amount of measured astigmatism in their glasses. Changes in spectacle lens power will be made as needed at follow-up visits to keep the level of under-correction within 0.50D of the target 3.00D. A program of visual engagement is also provided to encourage the normal development and use of accommodation. Treatment will continue for 15 months (until 18 months of age) or until the infant reaches a spherical equivalent refractive error of +3.00D or less hyperopia.<br>* Other names: Under-correction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperopia, ocular refraction, infant, vision