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

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ClinicalTrials.gov Identifier: NCT00214487
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Collaborator:
Johnson & Johnson Vision Care, Inc.
Information provided by (Responsible Party):
Thomas A. Aller, OD, Aller, Thomas A., OD

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Myopia Esophoria Fixation Disparity Device: Bifocal Contact Lenses Device: Placebo Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Bifocal Soft Contact Lenses - Do They Slow Progression of Myopia Relative to Single Vision Soft Contact Lenses in Children and Adolescents?
Study Start Date : October 2003
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Cycloplegic Autorefraction in One Year. [ Time Frame: One year ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214487


Sponsors and Collaborators
Aller, Thomas A., OD
Johnson & Johnson Vision Care, Inc.
Investigators
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Principal Investigator: Thomas A. Aller, O.D.
More Information
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Additional Information:

Publications of Results:
Aller TA, Wildsoet C. Results of a one-year prospective clinical trial (CONTROL) of the use of bifocal soft contact lenses to control myopia progression. Ophthalmic and Physiological Optics 26(S1), 8-9.

Other Publications:
Aller TA. Design of a prospective clinical trial of the use of bifocal soft contact lenses to control myopia progression (CONTROL). Proceedings of the 10th International Myopia Conference 2004:29.

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Responsible Party: Thomas A. Aller, OD, Principal Investigator, Aller, Thomas A., OD
ClinicalTrials.gov Identifier: NCT00214487    
Other Study ID Numbers: CR-0107
First Posted: September 22, 2005    Key Record Dates
Results First Posted: July 22, 2014
Last Update Posted: July 22, 2014
Last Verified: June 2014
Keywords provided by Thomas A. Aller, OD, Aller, Thomas A., OD:
Myopia Progression
Myopia Control
Bifocal Contact Lenses
Esophoria
Fixation Disparity
Additional relevant MeSH terms:
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Myopia
Esotropia
Disease Progression
Disease Attributes
Pathologic Processes
Refractive Errors
 Eye Diseases
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases