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
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
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
NCT ID
NCT00214487
First Posted
September 14, 2005
Last Updated
June 23, 2014
Sponsor
Aller, Thomas A., OD
Collaborators
Johnson & Johnson Vision Care, Inc.
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
Learn more about this trial
Bifocal Soft Contact Lenses and Their Effect on Myopia Progression in Children and Adolescents.
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