Enhancement of Emmetropization in Hyperopic Infants

The Ohio State University

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Farsightedness; Hyperopia; Hypermetropia

Treatments: Procedure: Spectacles

Study type: Interventional

Funder types: Other

Identifiers

NCT00574717

2004H0157

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 6 patients

Sex: All

Ages: 8 to 20 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

A

Experimental group

Description:

Infants will receive spectacle under-correction of their hyperopia.

Treatment:

Procedure: Spectacles