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Bifocal Soft Contact Lenses and Their Effect on Myopia Progression in Children and Adolescents.

NCT00214487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2014-07-22

Study results available
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Summary

The purpose of this study is to determine whether bifocal soft contact lenses are effective in controlling the progression of myopia in children and adolescents that exhibit a tendency to excessively cross their eyes while reading (esophoria or eso fixation disparity). Several studies have demonstrated that bifocal or progressive multifocal spectacles are effective in slowing the progression of myopia in children either with near point esophoria and/or with inadequate focusing at near. A prominent theory for one cause of myopia progression is that poorly focused images on the back of the eye (retina) cause the eye to lengthen, causing an increase in myopia. Bifocal contact lenses may reduce this retinal defocus, reducing the stimulus to eye elongation, and thus may reduce myopia progression.

Conditions

  • Myopia
  • Esophoria
  • Fixation Disparity

Interventions

DEVICE

Bifocal Contact Lenses

Use of bifocal contact lenses of varying add powers to control the progression of myopia

DEVICE

Placebo Control

Single vision soft contact lenses

Sponsors & Collaborators

  • Johnson & Johnson Vision Care, Inc.

    collaborator INDUSTRY

  • Aller, Thomas A., OD

    lead OTHER

Principal Investigators

  • Thomas A. Aller, O.D.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2006-03-31
Completion
2006-03-31

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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 NCT00214487 on ClinicalTrials.gov