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

• Sponsor: Aller, Thomas A., OD (Other)
• Overall Status: Completed
• CT.gov ID: NCT00214487
• Collaborator: Johnson & Johnson Vision Care, Inc. (Industry)
• Enrollment: 78
• Arms: 2
• Duration (Months): 29

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Esophoria; Fixation Disparity	Device: Bifocal Contact Lenses; Device: Placebo Control	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Bifocal Soft Contact Lenses - Do They Slow Progression of Myopia Relative to Single Vision Soft Contact Lenses in Children and Adolescents?
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: Mar 1, 2006
• Actual Study Completion Date: Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bifocal Contact Lenses 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; Other Names: Bifocal Soft Contact Lenses Hydrophilic Bifocal Contact Lenses Simultaneous Vision Bifocal Contact Lenses
Placebo Comparator: Control Single vision soft contact lenses	Device: Placebo Control; Single vision soft contact lenses; Other Names: Soft Contact Lenses Hydrophilic Contact Lenses Single Vision Soft Contact Lenses

Outcome Measures

Primary Outcome Measures

1. Changes in Cycloplegic Autorefraction in One Year. [One year]

Secondary Outcome Measures

1. Keratometric Changes at One Year. [One year]

2. Changes in Manifest Refraction at One Year. [One year]

3. Relationship Between Residual Fixation Disparity and Myopia Progression. [One year]

4. Changes in Cycloplegic Subjective Refraction in One Year [One year]

5. Changes in Axial Length at One Year. [One year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• Aller, Thomas A., OD
• Johnson & Johnson Vision Care, Inc.

Investigators

• Principal Investigator: Thomas A. Aller, O.D.,

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here for more information about the CONTROL Study

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. Erratum in: Clin Exp Optom. 2008 Sep;91(5):479.
• 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.
• 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.

• Responsible Party: Thomas A. Aller, OD, Principal Investigator, Aller, Thomas A., OD
• ClinicalTrials.gov Identifier: NCT00214487
• Other Study ID Numbers: CR-0107
• First Posted: Sep 22, 2005
• Last Update Posted: Jul 22, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Thomas A. Aller, OD, Principal Investigator, Aller, Thomas A., OD: Myopia Progression; Myopia Control; Bifocal Contact Lenses; Esophoria; Fixation Disparity
• Additional relevant MeSH terms: Esotropia; Myopia; Disease Progression

Study Results

Participant Flow

Arm/Group Title	Bifocal Contact Lenses	Control
Arm/Group Description	Use of bifocal contact lenses to control the progression of myopia Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia	Single vision soft contact lenses Placebo Control: Single vision soft contact lenses
Period Title: Overall Study
STARTED	43	43
COMPLETED	38	40
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Bifocal Contact Lenses	Control	Total
Arm/Group Description	Use of bifocal contact lenses to control the progression of myopia Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia	Single vision soft contact lenses Placebo Control: Single vision soft contact lenses	Total of all reporting groups
Overall Participants	38	40	78
Age (Count of Participants)
<=18 years	38 100%	40 100%	78 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	27 71.1%	27 67.5%	54 69.2%
Male	11 28.9%	13 32.5%	24 30.8%

Outcome Measures

1. Primary Outcome

Title	Changes in Cycloplegic Autorefraction in One Year.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bifocal Contact Lenses	Control
Arm/Group Description	Use of bifocal contact lenses to control the progression of myopia Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia	Single vision soft contact lenses Placebo Control: Single vision soft contact lenses
Measure Participants	38	40
Mean (Standard Deviation) [Diopters]	-0.22 (0.34)	-0.78 (0.45)

2. Secondary Outcome

Title	Keratometric Changes at One Year.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Changes in Manifest Refraction at One Year.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Relationship Between Residual Fixation Disparity and Myopia Progression.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Changes in Cycloplegic Subjective Refraction in One Year
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Changes in Axial Length at One Year.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	1 year
Arm/Group Title	Bifocal Contact Lenses		Control
Arm/Group Description	Use of bifocal contact lenses to control the progression of myopia Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia		Single vision soft contact lenses Placebo Control: Single vision soft contact lenses
All Cause Mortality
	Bifocal Contact Lenses		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bifocal Contact Lenses		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Bifocal Contact Lenses		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Investigator acknowledges that the data to be collected is proprietary. The Investigator agrees not to publish, divulge, reveal, disclose or otherwise make available, the data to others without the permission of sponsor unless the data have already been, or are subsequently published or disclosed by order of a court of law. The Investigator will not be free to publish papers dealing with the results of any Research performed under this Agreement without the consent of sponsor.