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Enhancement of Emmetropization in Hyperopic Infants

NCT00574717 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2012-10-19

No results posted yet for this study

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.

Conditions

  • Hyperopia
  • Hypermetropia
  • Farsightedness

Interventions

PROCEDURE

Spectacles

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.

Sponsors & Collaborators

  • The Ohio Lions Eye Research Foundation

    collaborator UNKNOWN

  • Ohio State University

    lead OTHER

Principal Investigators

  • Donald O. Mutti, OD, PhD · The Ohio State University College of Optometry

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Weeks
Max Age
20 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00574717 on ClinicalTrials.gov