Enhancement of Emmetropization in Hyperopic Infants

Hyperopia Clinical Trial

Official title: Enhancement of Emmetropization in Hyperopic Infants

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Farsightedness
• Hypermetropia
• Hyperopia

• NCT number: NCT00574717
• Study type: Interventional
• Source: Ohio State University
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: December 2007
• Completion date: September 2010