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Completed

NCT Number: NCT00214487

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

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.

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Key information

Conditions

Myopia Cranial Nerve Diseases Esophoria Esotropia Eye Diseases Fixation Disparity Nervous System Diseases Ocular Motility Disorders Refractive Errors Strabismus

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Myopia has become the focus of growing attention and concern because the prevalence of myopia appears to increasing in some populations (reaching 90% for some university student populations in Asia). There are serious risks to higher levels of myopia, including cataracts, glaucoma, retinal detachment and myopic retinal degeneration. Several studies have shown mild to moderate control of myopia progressionwith bifocal or multifocal spectacles in children with esophoria at near and/or with accommodative deficiencies. Pilot studies by the P.I. have suggested that bifocal contact lenses may control myopia progression in children with near point eso fixation disparity.

CONTROL is a controlled, randomized, prospective, double-blind, one year study of the changes in myopia in 80-90 subjects from age 8-18 with low to moderate levels of myopia, low levels of astigmatism, and eso fixation disparity at near, when fitted with either bifocal soft contact lenses or single vision soft contact lenses. The primary outcome measures will be cycloplegic refraction and axial length measures.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Myopia between -0.50 and -6.00
  • Eso fixation disparity at 33cm with distance correction
  • Astigmatism 1.00 or less
  • Ability to wear soft contact lenses

Exclusion criteria

  • Presence of ocular disease preventing wear of contacts
  • Pregnancy or nursing
  • Use of certain medications

Treatment and study plan

Bifocal Contact Lenses

Device

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

Other names: Bifocal Soft Contact Lenses, Hydrophilic Bifocal Contact Lenses, Simultaneous Vision Bifocal Contact Lenses

Placebo Control

Device

Single vision soft contact lenses

Other names: Soft Contact Lenses, Hydrophilic Contact Lenses, Single Vision Soft Contact Lenses

Primary outcomes

  1. Changes in Cycloplegic Autorefraction in One Year.

    Time frame: One year

Secondary outcomes

  1. Keratometric Changes at One Year.

    Time frame: One year

  2. Changes in Manifest Refraction at One Year.

    Time frame: One year

  3. Relationship Between Residual Fixation Disparity and Myopia Progression.

    Time frame: One year

  4. Changes in Cycloplegic Subjective Refraction in One Year

    Time frame: One year

  5. Changes in Axial Length at One Year.

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Aller, Thomas A., OD

Other

Collaborators

  • Johnson & Johnson Vision Care, Inc.

Registry information

Official study title

Bifocal Soft Contact Lenses - Do They Slow Progression of Myopia Relative to Single Vision Soft Contact Lenses in Children and Adolescents?

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Jul 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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