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

June 23, 2014 updated by: Thomas A. Aller, OD, Aller, Thomas A., OD

Bifocal Soft Contact Lenses - Do They Slow Progression of Myopia Relative to Single Vision Soft Contact Lenses 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bifocal Contact Lenses
Use of bifocal contact lenses to control the progression of myopia
Device: Bifocal Contact Lenses
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 Comparator: Control
Single vision soft contact lenses
Device: Placebo Control
Single vision soft contact lenses
Other Names:
  • Soft Contact Lenses
  • Hydrophilic Contact Lenses
  • Single Vision Soft Contact Lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Cycloplegic Autorefraction in One Year.
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Keratometric Changes at One Year.
Time Frame: One year
One year
Changes in Manifest Refraction at One Year.
Time Frame: One year
One year
Relationship Between Residual Fixation Disparity and Myopia Progression.
Time Frame: One year
One year
Changes in Cycloplegic Subjective Refraction in One Year
Time Frame: One year
One year
Changes in Axial Length at One Year.
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aller, Thomas A., OD

Collaborators

Johnson & Johnson Vision Care, Inc.

Investigators

  • Principal Investigator: Thomas A. Aller, O.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

July 22, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-0107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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