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?
1 other identifier
interventional
78
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2003
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedResults Posted
Study results publicly available
July 22, 2014
CompletedJuly 22, 2014
June 1, 2014
2.4 years
September 14, 2005
June 23, 2014
June 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Cycloplegic Autorefraction in One Year.
One year
Secondary Outcomes (5)
Keratometric Changes at One Year.
One year
Changes in Manifest Refraction at One Year.
One year
Relationship Between Residual Fixation Disparity and Myopia Progression.
One year
Changes in Cycloplegic Subjective Refraction in One Year
One year
Changes in Axial Length at One Year.
One year
Study Arms (2)
Bifocal Contact Lenses
EXPERIMENTALUse of bifocal contact lenses to control the progression of myopia
Control
PLACEBO COMPARATORSingle vision soft contact lenses
Interventions
Use of bifocal contact lenses of varying add powers to control the progression of myopia
Single vision soft contact lenses
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Presence of ocular disease preventing wear of contacts
- Pregnancy or nursing
- Use of certain medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aller, Thomas A., ODlead
- Johnson & Johnson Vision Care, Inc.collaborator
Related Publications (5)
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.
PMID: 18601670BACKGROUNDTarrant 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.
PMID: 18201337BACKGROUNDAller 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.
BACKGROUNDAller 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.
RESULTLawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
PMID: 36809645DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Thomas Aller
- Organization
- Dr. Thomas Aller, Optometrist Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas A. Aller, O.D.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 22, 2005
Study Start
October 1, 2003
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
July 22, 2014
Results First Posted
July 22, 2014
Record last verified: 2014-06