Enhancement of Emmetropization in Hyperopic Infants

Phase 1

Terminated

• Conditions: Hyperopia; Hypermetropia; Farsightedness
• Interventions: Procedure: Spectacles

• Registration Number: NCT00574717
• Lead Sponsor: Ohio State University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-17
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-18
• Last Update Posted: 2012-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Spectacles	Infants will receive spectacle under-correction of their hyperopia.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Ohio State University College of Optometry; 🇺🇸 Columbus, Ohio, United States