Bifocal Soft Contact Lenses and Their Effect on Myopia Progression in Children and Adolescents. - Full Text View

Sponsors and Collaborators:	Aller, Thomas A., OD Vistakon, a division of Johnson & Johnson Vision Care, Inc.
Information provided by:	Aller, Thomas A., OD
ClinicalTrials.gov Identifier:	NCT00214487

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

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Bifocal Soft Contact Lenses - Do They Slow Progression of Myopia Relative to Single Vision Soft Contact Lenses in Children and Adolescents?

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
Bifocal Contact Lenses: Experimental 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
Control: Placebo Comparator Single vision soft contact lenses	Device: Placebo Control 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

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

Sponsors and Collaborators

Aller, Thomas A., OD

Vistakon, a division of Johnson & Johnson Vision Care, Inc.

Investigators

Principal Investigator:

Thomas A. Aller, O.D.

Unaffiliated

More Information

Click here for more information about the CONTROL Study This link exits the ClinicalTrials.gov site

Myopia research web page This link exits the ClinicalTrials.gov site

Publications:

Aller TA, Wildsoet C. Bifocal soft contact lenses as a possible myopia control treatment: a case report involving identical twins. Clin Exp Optom. 2008 Jul;91(4):394-9. Erratum in: Clin Exp Optom. 2008 Sep;91(5):479.

Tarrant J, Severson H, Wildsoet CF. Accommodation in emmetropic and myopic young adults wearing bifocal soft contact lenses. Ophthalmic Physiol Opt. 2008 Jan;28(1):62-72.

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:	Dr. Thomas Aller Optometrist, Inc. ( Thomas Aller, OD )
Study ID Numbers:	CR-0107, CONTROL
Study First Received:	September 14, 2005
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00214487
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

Study placed in the following topic categories:

Esotropia
Ocular Motility Disorders
Motor neuro-ophthalmic disorders
Eye Diseases
Strabismus

Disease Progression
Myopia
Ocular motility disorders
Refractive Errors

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Nervous System Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on January 16, 2009