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Trial record 1 of 1 for:    NCT02255474
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Bifocal Lenses In Nearsighted Kids (BLINK)

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ClinicalTrials.gov Identifier: NCT02255474
Recruitment Status : Active, not recruiting
First Posted : October 2, 2014
Last Update Posted : September 26, 2017
Sponsor:
Collaborators:
University of Houston
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jeffrey J. Walline, OD PhD, Ohio State University

Brief Summary:
This study will evaluate the use of two different bifocal contact lens add powers to prevent further nearsighted progression in children ages 7 to 11 years old. It is theorized that the profile of the bifocal lenses will decrease the amount of change in nearsightedness that the children experience.

Condition or disease Intervention/treatment Phase
Refractive Errors Device: Biofinity Multifocal D +1.50 add Device: Biofinity Multifocal D +2.50 add Device: Biofinity Not Applicable

Detailed Description:

The primary goal of this project is to determine whether a commercially available soft bifocal contact lens with a distance-center design can slow myopia progression in children. Using soft bifocal contact lenses to manipulate the peripheral optics of the eye is a novel use for a standard contact lens that may keep children from becoming as nearsighted as they would otherwise. Secondary goals are to determine whether the amount of myopic defocus imposed on the peripheral retina by soft bifocal contact lenses is associated in a dose-dependent manner with slowed myopic progression and to determine whether peripheral myopic blur acts to slow eye growth locally or globally. These important pieces of information will enable investigators to learn about the role of peripheral optics for regulating eye growth, which could ultimately lead to optimization of optical signals to slow myopia progression. Ultimately, the information could be used to design optical devices to prevent the onset of myopia in young children.

Slowing myopia progression or eventually preventing myopia onset could potentially affect approximately 60 million children in the United States alone. While the consequences of myopia are rarely sight-threatening, the quality of life for myopic patients is negatively affected and the health care costs to treat myopia are astronomical (approximately $4.6 billion in 1990). The National Eye Institute recognizes the need to "evaluate the efficacy of potential treatments for delaying the onset or for slowing the progression of myopia, such as lenses that alter peripheral defocus."

Using a common treatment of myopia (contact lenses) to potentially slow myopia progression and to learn about optical signals that regulate eye growth is a very novel approach to solving a problem that affects a large proportion of people in the United States.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Soft Bifocal Contact Lens Myopia Control
Study Start Date : September 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Biofinity
Soft spherical contact lens
Device: Biofinity
This is a monthly disposable spherical contact lens commercially available from CooperVision

Experimental: Biofinity Multifocal D +1.50 add
The Biofinity Multifocal "D" with a +1.50 add is a soft bifocal contact lens that has a medium reading power
Device: Biofinity Multifocal D +1.50 add
This is a monthly disposable contact lens commercially available from CooperVision

Experimental: Biofinity Multifocal D +2.50 add
The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power
Device: Biofinity Multifocal D +2.50 add
This is a monthly disposable contact lens commercially available from CooperVision




Primary Outcome Measures :
  1. Refractive error progression [ Time Frame: 3 years ]
    Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).


Secondary Outcome Measures :
  1. Ocular shape change and eye growth [ Time Frame: 3 years ]
    The outcome of interest is the change in ocular shape and measured by the change in peripheral refractive error in the right eye. The change in peripheral refractive error will be compared among the two treatment groups and the control group to determine whether peripheral defocus changes the shape of the eye globally (across the whole eye) or locally (specific to the region of the eye affected by the defocus).

  2. Association of peripheral defocus to myopic progression [ Time Frame: 3 years ]
    Peripheral defocus will be measured in 10 areas (Nasal and temporal zones at 20, 30, and 40 degrees, and superior and inferior zones at 20 and 30 degrees) and analyzed for its relation to myopia progression (as measured by cycloplegic autorefraction in the right eye only).

  3. Axial length progression [ Time Frame: 3 years ]
    Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 7 to 11 years, inclusive, at baseline examination
  • -0.75 to -5.00 D, inclusive, spherical component, cycloplegic autorefraction
  • ≤1.00 DC, cycloplegic autorefraction
  • ≥ 2.00 D difference between the sphere components of the two eyes (anisometropia), cycloplegic autorefraction
  • 0.1 logMAR or better best-corrected visual acuity in each eye
  • 0.1 logMAR or better visual acuity OU distance and near with a +2.50 D add contact lens
  • +2.50 D add lens provides adequate fit with respect to movement and centration

Exclusion Criteria:

  • Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
  • Systemic disease that may affect vision, vision development, or contact lens wear (eg, diabetes, Down syndrome, etc.)
  • Previous gas permeable, soft bifocal, or orthokeratology contact lens wear or bifocal/PAL spectacle wear (longer than 1 month of wear)
  • Previous or current participation in myopia control studies
  • Chronic use of medications that may affect immunity, such as oral or ophthalmic corticosteroids for ocular or systemic diseases
  • Issues that may interfere with the ability to participate over the next 3 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255474


Locations
United States, Ohio
Ohio State University College of Optometry
Columbus, Ohio, United States, 43210
United States, Texas
University of Houston College of Optometry
Houston, Texas, United States, 77204
Sponsors and Collaborators
Ohio State University
University of Houston
National Eye Institute (NEI)
Investigators
Study Chair: Jeffrey Walline, OD, PhD Ohio State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey J. Walline, OD PhD, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02255474     History of Changes
Other Study ID Numbers: 2014H0231
U10EY023208 ( U.S. NIH Grant/Contract )
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017

Keywords provided by Jeffrey J. Walline, OD PhD, Ohio State University:
pediatrics
refractive error - myopia
contact lenses
intervention

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases