Bifocal Lenses In Nearsighted Kids

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.

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