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 (Responsible Party):
Thomas A. Aller, OD, Aller, Thomas A., OD
ClinicalTrials.gov Identifier:
NCT00214487
First received: September 14, 2005
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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 Intervention
Myopia
Esophoria
Fixation Disparity
Device: Bifocal Contact Lenses
Device: Placebo Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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?

Resource links provided by NLM:


Further study details as provided by Aller, Thomas A., OD:

Primary Outcome Measures:
  • Changes in Cycloplegic Autorefraction in One Year. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 78
Study Start Date: October 2003
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Contact Lenses
  • 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

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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214487

Sponsors and Collaborators
Aller, Thomas A., OD
Vistakon
Investigators
Principal Investigator: Thomas A. Aller, O.D.
  More Information

Additional Information:
Publications:
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.
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.

Responsible Party: Thomas A. Aller, OD, Principal Investigator, Aller, Thomas A., OD
ClinicalTrials.gov Identifier: NCT00214487     History of Changes
Other Study ID Numbers: CR-0107
Study First Received: September 14, 2005
Results First Received: June 23, 2014
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aller, Thomas A., OD:
Myopia Progression
Myopia Control
Bifocal Contact Lenses
Esophoria
Fixation Disparity

Additional relevant MeSH terms:
Disease Progression
Myopia
Disease Attributes
Eye Diseases
Pathologic Processes
Refractive Errors

ClinicalTrials.gov processed this record on October 23, 2014