MyopiaNCT00214487

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

A study testing Bifocal Contact Lenses in people with Myopia and Esophoria, run by Aller, Thomas A., OD.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 8 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Myopia, Esophoria, Fixation Disparity
What is being tested?: Bifocal Contact Lenses
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 78 participants
Where: No sites listed yet
Study dates: Oct 2003to Mar 2006
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

Presence of ocular disease preventing wear of contacts
Pregnancy or nursing
Use of certain medications

About this study

Official title: Bifocal Soft Contact Lenses - Do They Slow Progression of Myopia Relative to Single Vision Soft Contact Lenses in Children and Adolescents?

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.

Read the 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.

Conditions: Myopia, Esophoria, Fixation Disparity
Being tested: Bifocal Contact Lenses, Placebo Control
Keywords: Myopia Progression, Myopia Control, Bifocal Contact Lenses, Esophoria, Fixation Disparity
Medical subject headings: Myopia, Esotropia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bifocal Contact LensesDevice
Also called Bifocal Soft Contact Lenses, Hydrophilic Bifocal Contact Lenses, Simultaneous Vision Bifocal Contact Lenses
Use of bifocal contact lenses of varying add powers to control the progression of myopia
Placebo ControlDevice
Also called Soft Contact Lenses, Hydrophilic Contact Lenses, Single Vision Soft Contact Lenses
Single vision soft contact lenses

Study groups in NCT00214487
Study group	Role	What they receive
Bifocal Contact Lenses	Experimental	Use of bifocal contact lenses to control the progression of myopia Receives: Device: Bifocal Contact Lenses
Control	Placebo comparator	Single vision soft contact lenses Receives: Device: Placebo Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Cycloplegic Autorefraction in One Year.
Measured: One year

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2003Mar 2006

First posted22 Sep 2005 (estimated)
Study startOct 2003
Primary completionMar 2006
Study completionMar 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for MyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00214487
Sponsor's protocol ID: CR-0107
Status last verified: Jun 2014
First submitted: 14 Sep 2005
Last updated: 22 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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. doi: 10.1111/j.1444-0938.2007.00230.x.
PubMed 18601670
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.
PubMed 18201337
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.
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.
Lawrenson 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.
PubMed 36809645

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
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Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bifocal Soft Contact Lenses - Do They Slow Progression of Myopia Relative to Single Vision Soft Contact Lenses in Children and Adolescents?
ClinicalTrials.gov ID: NCT00214487
Acronym / sponsor ID: CR-0107
Conditions: Myopia, Esophoria, Fixation Disparity
Keywords: Myopia Progression, Myopia Control, Bifocal Contact Lenses, Esophoria, Fixation Disparity
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Aller, Thomas A., ODUniversity, hospital or other
Collaborators: Johnson & Johnson Vision Care, Inc.
Study start: Oct 2003
Primary completion: Mar 2006 (actual)
Study completion: Mar 2006 (actual)
First posted: 22 Sep 2005 (estimated)
Results: Posted 22 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Bifocal Contact Lenses	Experimental	Device: Bifocal Contact LensesUse of bifocal contact lenses to control the progression of myopia
Control	Placebo comparator	Device: Placebo ControlSingle vision soft contact lenses

Who may qualify

Ages: 8 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

Presence of ocular disease preventing wear of contacts
Pregnancy or nursing
Use of certain medications

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bifocal Contact LensesAlso: Bifocal Soft Contact Lenses, Hydrophilic Bifocal Contact Lenses, Simultaneous Vision Bifocal Contact LensesUse of bifocal contact lenses of varying add powers to control the progression of myopia	Device	Bifocal Contact Lenses
Placebo ControlAlso: Soft Contact Lenses, Hydrophilic Contact Lenses, Single Vision Soft Contact LensesSingle vision soft contact lenses	Device	Control

Primary outcome

Changes in Cycloplegic Autorefraction in One Year.
Time frame: One year

5 secondary outcomes

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

Results and safety

Results posted to the registry on 22 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bifocal Contact Lenses	43	38
Control	43	40

Primary outcome: Changes in Cycloplegic Autorefraction in One Year.

Time frame: One year. Mean (Standard Deviation). Unit: Diopters

Measure	Bifocal Contact Lenses n = 38	Control n = 40
Value	-0.22 (0.34)	-0.78 (0.45)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bifocal Contact Lenses	0 of 38 (0%)	0 of 38 (0%)	Not reported
Control	0 of 40 (0%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18601670Aller 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.
Background: PubMed 18201337Tarrant 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.
BackgroundAller 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 publicationAller 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.
Derived from this study: PubMed 36809645Lawrenson 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.
Click here for more information about the CONTROL StudyLink provided by the sponsor.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas A. Aller, O.D. principal investigator

Questions about this trial

What is this clinical trial studying?

A study testing Bifocal Contact Lenses in people with Myopia and Esophoria, run by Aller, Thomas A., OD.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Cycloplegic Autorefraction in One Year. (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00214487, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2014.