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

This study has been completed.
Sponsor:
Collaborator:
Vistakon
Information provided by:
Aller, Thomas A., OD
ClinicalTrials.gov Identifier:
NCT00214487
First received: September 14, 2005
Last updated: November 3, 2008
Last verified: November 2008

September 14, 2005
November 3, 2008
October 2003
March 2006   (final data collection date for primary outcome measure)
Changes in cycloplegic autorefraction in one year. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Changes in cycloplegic autorefraction in one year.
  • Changes in cycloplegic subjective refraction in one year.
  • Changes in axial length at one year.
Complete list of historical versions of study NCT00214487 on ClinicalTrials.gov Archive Site
  • Keratometric changes at one year. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Changes in manifest refraction at one year. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Relationship between residual fixation disparity and myopia progression. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Changes in cycloplegic subjective refraction in one year [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Changes in axial length at one year. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Keratometric changes at one year.
  • Changes in manifest refraction at one year.
  • Relationship between residual fixation disparity and myopia progression.
Not Provided
Not Provided
 
Bifocal Soft Contact Lenses and Their Effect on Myopia Progression in Children and Adolescents.
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Myopia
  • Esophoria
  • Fixation Disparity
  • Device: Bifocal Contact Lenses
    Use of bifocal contact lenses of varying add powers to control the progression of myopia
    Other Names:
    • Bifocal Contact Lenses
    • Bifocal Soft Contact Lenses
    • Hydrophilic Bifocal Contact Lenses
    • Simultaneous Vision Bifocal Contact Lenses
  • Device: Placebo Control
    Single vision soft contact lenses
    Other Names:
    • Soft Contact Lenses
    • Hydrophilic Contact Lenses
    • Single Vision Soft Contact Lenses
  • Experimental: Bifocal Contact Lenses
    Use of bifocal contact lenses to control the progression of myopia
    Intervention: Device: Bifocal Contact Lenses
  • Placebo Comparator: Control
    Single vision soft contact lenses
    Intervention: Device: Placebo Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
March 2006
March 2006   (final data collection date for primary outcome measure)

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
Both
8 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00214487
CR-0107, CONTROL
No
Thomas Aller, OD, Dr. Thomas Aller Optometrist, Inc.
Aller, Thomas A., OD
Vistakon
Principal Investigator: Thomas A. Aller, O.D.
Aller, Thomas A., OD
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP