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

Primary Purpose

Myopia, Esophoria, Fixation Disparity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bifocal Contact Lenses
Placebo Control
Sponsored by
Aller, Thomas A., OD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia focused on measuring Myopia Progression, Myopia Control, Bifocal Contact Lenses, Esophoria, Fixation Disparity

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Bifocal Contact Lenses

    Control

    Arm Description

    Use of bifocal contact lenses to control the progression of myopia

    Single vision soft contact lenses

    Outcomes

    Primary Outcome Measures

    Changes in Cycloplegic Autorefraction in One Year.

    Secondary Outcome Measures

    Keratometric Changes at One Year.
    Changes in Manifest Refraction at One Year.
    Relationship Between Residual Fixation Disparity and Myopia Progression.
    Changes in Cycloplegic Subjective Refraction in One Year
    Changes in Axial Length at One Year.

    Full Information

    First Posted
    September 14, 2005
    Last Updated
    June 23, 2014
    Sponsor
    Aller, Thomas A., OD
    Collaborators
    Johnson & Johnson Vision Care, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00214487
    Brief Title
    Bifocal Soft Contact Lenses and Their Effect on Myopia Progression in Children and Adolescents.
    Official Title
    Bifocal Soft Contact Lenses - Do They Slow Progression of Myopia Relative to Single Vision Soft Contact Lenses in Children and Adolescents?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2003 (undefined)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    March 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aller, Thomas A., OD
    Collaborators
    Johnson & Johnson Vision Care, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Esophoria, Fixation Disparity
    Keywords
    Myopia Progression, Myopia Control, Bifocal Contact Lenses, Esophoria, Fixation Disparity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    78 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bifocal Contact Lenses
    Arm Type
    Experimental
    Arm Description
    Use of bifocal contact lenses to control the progression of myopia
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Single vision soft contact lenses
    Intervention Type
    Device
    Intervention Name(s)
    Bifocal Contact Lenses
    Other Intervention Name(s)
    Bifocal Soft Contact Lenses, Hydrophilic Bifocal Contact Lenses, Simultaneous Vision Bifocal Contact Lenses
    Intervention Description
    Use of bifocal contact lenses of varying add powers to control the progression of myopia
    Intervention Type
    Device
    Intervention Name(s)
    Placebo Control
    Other Intervention Name(s)
    Soft Contact Lenses, Hydrophilic Contact Lenses, Single Vision Soft Contact Lenses
    Intervention Description
    Single vision soft contact lenses
    Primary Outcome Measure Information:
    Title
    Changes in Cycloplegic Autorefraction in One Year.
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    Keratometric Changes at One Year.
    Time Frame
    One year
    Title
    Changes in Manifest Refraction at One Year.
    Time Frame
    One year
    Title
    Relationship Between Residual Fixation Disparity and Myopia Progression.
    Time Frame
    One year
    Title
    Changes in Cycloplegic Subjective Refraction in One Year
    Time Frame
    One year
    Title
    Changes in Axial Length at One Year.
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas A. Aller, O.D.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18601670
    Citation
    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. doi: 10.1111/j.1444-0938.2007.00230.x. Erratum In: Clin Exp Optom. 2008 Sep;91(5):479.
    Results Reference
    background
    PubMed Identifier
    18201337
    Citation
    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. doi: 10.1111/j.1475-1313.2007.00529.x.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    result
    Links:
    URL
    http://www.draller.com
    Description
    Click here for more information about the CONTROL Study

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

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