Myopia Progression With a Novel Extended Depth of Focus Contact Lens
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 5 - 25 |
| Updated: | 12/6/2017 |
| Start Date: | January 1, 2017 |
| End Date: | January 1, 2020 |
Myopia Progression in Children and Adolescents Before and After Use of a Novel Extended Depth of Focus Daily Disposable Soft Contact Lens
Myopia has been increasing in prevalence and severity throughout the world over the last 30
years. Increasing levels of myopia are associated with increased frequencies and severity of
various ocular pathologies, including cataracts, glaucoma, retinal detachments and other
retinal pathologies and myopic maculopathy. Slowing myopia progression at a young age before
the eye reaches excessive axial length may help to reduce the future risks of these ocular
pathologies.
Conventional spectacles and contact lenses are prescribed correct myopia by moving the
central focus of the eye for distance viewing from in front of the retina to on the retina
centrally, or at the fovea. To varying degrees, these lenses allow the light to focus behind
the retina, at varying peripheral retinal locations. These findings have led to efforts to
design spectacle and contact lenses which correct peripheral hyperopic defocus, to reduce
myopia progression.
The consensus theory for how both multifocal contact lenses and orthokeratology can control
myopia progression is that they each can reduce, eliminate, or reverse relative peripheral
hyperopic defocus. Existing published studies on the use of multifocal contact lenses to
control myopia in humans have utilized lenses with the distance correction in the center with
peripheral plus power to correct the peripheral blur. Until recently, there have been no
daily disposable multifocal lenses in the US market with distance center designs.
The NaturalVue contact lens from Visioneering Technologies, Inc. is the first daily
disposable distance center multifocal in the US. It has a novel extended depth of focus
design where the distance correction is in the center of the optical zone, surrounded by a
zone characterized by having a seamless, rapid transition from the distance power to a highly
plus power at the edge of the optical zone.
This study will analyze the myopia progression of patients in the investigator's practice
while wearing their habitual visual corrections for periods up to two years prior to being
switched to NaturalVue contact lenses. They will then be followed for up to two years after
beginning use of this novel lens design and the differences in their myopia progression after
versus before this novel lens will be analyzed. Axial lengths will be measured with the
IOLMaster after switching to NaturalVue, at six-month intervals and will be compared to axial
lengths which have been collected with habitual corrections.
years. Increasing levels of myopia are associated with increased frequencies and severity of
various ocular pathologies, including cataracts, glaucoma, retinal detachments and other
retinal pathologies and myopic maculopathy. Slowing myopia progression at a young age before
the eye reaches excessive axial length may help to reduce the future risks of these ocular
pathologies.
Conventional spectacles and contact lenses are prescribed correct myopia by moving the
central focus of the eye for distance viewing from in front of the retina to on the retina
centrally, or at the fovea. To varying degrees, these lenses allow the light to focus behind
the retina, at varying peripheral retinal locations. These findings have led to efforts to
design spectacle and contact lenses which correct peripheral hyperopic defocus, to reduce
myopia progression.
The consensus theory for how both multifocal contact lenses and orthokeratology can control
myopia progression is that they each can reduce, eliminate, or reverse relative peripheral
hyperopic defocus. Existing published studies on the use of multifocal contact lenses to
control myopia in humans have utilized lenses with the distance correction in the center with
peripheral plus power to correct the peripheral blur. Until recently, there have been no
daily disposable multifocal lenses in the US market with distance center designs.
The NaturalVue contact lens from Visioneering Technologies, Inc. is the first daily
disposable distance center multifocal in the US. It has a novel extended depth of focus
design where the distance correction is in the center of the optical zone, surrounded by a
zone characterized by having a seamless, rapid transition from the distance power to a highly
plus power at the edge of the optical zone.
This study will analyze the myopia progression of patients in the investigator's practice
while wearing their habitual visual corrections for periods up to two years prior to being
switched to NaturalVue contact lenses. They will then be followed for up to two years after
beginning use of this novel lens design and the differences in their myopia progression after
versus before this novel lens will be analyzed. Axial lengths will be measured with the
IOLMaster after switching to NaturalVue, at six-month intervals and will be compared to axial
lengths which have been collected with habitual corrections.
Myopia has been increasing in prevalence and severity throughout the world over the last 30
years. Increasing levels of myopia are associated with increased frequencies and severity of
various ocular pathologies, including cataracts, glaucoma, retinal detachments and other
retinal pathologies and myopic maculopathy. Slowing myopia progression at a young age before
the eye reaches excessive axial length may help to reduce the future risks of these ocular
pathologies.
Conventional spectacles and contact lenses are prescribed to correct myopia by moving the
central focus of the eye for distance viewing from in front of the retina to on the retina
centrally, or at the fovea. To varying degrees, these lenses allow the light to focus behind
the retina, at varying peripheral retinal locations. These findings have led to efforts to
design spectacle and contact lenses which correct peripheral blur to reduce myopia
progression.
The consensus theory for how both multifocal contact lenses and orthokeratology can control
myopia progression is that they each can reduce, eliminate, or reverse relative peripheral
hyperopic defocus. Existing published studies on the use of multifocal contact lenses to
control myopia in humans have utilized lenses with the distance correction in the center with
peripheral plus power to correct the peripheral hyperopic defocus. Until recently, there have
been no daily disposable multifocal lenses in the US market with distance center designs.
The NaturalVue contact lens from Visioneering Technologies, Inc. is the first daily
disposable distance center multifocal in the US. It has a novel extended depth of focus
design where the distance correction is in the center of the optical zone, surrounded by a
zone with a seamless, rapid transition from the distance power to a highly plus power at the
edge of the optical zone.
This study will analyze the myopia progression of patients in the investigator's practice
while wearing their habitual visual corrections for periods up to two years prior to being
switched to NaturalVue contact lenses. They will then be followed for up to two years after
beginning use of this novel lens design and the differences in their myopia progression after
NaturalVue versus before NaturalVue will be analyzed. Axial lengths will be measured with the
IOLMaster after switching to NaturalVue, at six-month intervals and will be compared to axial
lengths which have been collected with habitual corrections.
years. Increasing levels of myopia are associated with increased frequencies and severity of
various ocular pathologies, including cataracts, glaucoma, retinal detachments and other
retinal pathologies and myopic maculopathy. Slowing myopia progression at a young age before
the eye reaches excessive axial length may help to reduce the future risks of these ocular
pathologies.
Conventional spectacles and contact lenses are prescribed to correct myopia by moving the
central focus of the eye for distance viewing from in front of the retina to on the retina
centrally, or at the fovea. To varying degrees, these lenses allow the light to focus behind
the retina, at varying peripheral retinal locations. These findings have led to efforts to
design spectacle and contact lenses which correct peripheral blur to reduce myopia
progression.
The consensus theory for how both multifocal contact lenses and orthokeratology can control
myopia progression is that they each can reduce, eliminate, or reverse relative peripheral
hyperopic defocus. Existing published studies on the use of multifocal contact lenses to
control myopia in humans have utilized lenses with the distance correction in the center with
peripheral plus power to correct the peripheral hyperopic defocus. Until recently, there have
been no daily disposable multifocal lenses in the US market with distance center designs.
The NaturalVue contact lens from Visioneering Technologies, Inc. is the first daily
disposable distance center multifocal in the US. It has a novel extended depth of focus
design where the distance correction is in the center of the optical zone, surrounded by a
zone with a seamless, rapid transition from the distance power to a highly plus power at the
edge of the optical zone.
This study will analyze the myopia progression of patients in the investigator's practice
while wearing their habitual visual corrections for periods up to two years prior to being
switched to NaturalVue contact lenses. They will then be followed for up to two years after
beginning use of this novel lens design and the differences in their myopia progression after
NaturalVue versus before NaturalVue will be analyzed. Axial lengths will be measured with the
IOLMaster after switching to NaturalVue, at six-month intervals and will be compared to axial
lengths which have been collected with habitual corrections.
Inclusion Criteria:
- Myopic refractive error
- Astigmatism less than -2.50 D
- Evidence from clinical record of myopia progression equal to or greater than -0.50 D
in at least one eye since the prior examination
- Ability to see 20/30 or better in the worse eye and 20/25 or better binocularly after
one week adaptation
- Ability to properly insert, remove and care for study lens
Exclusion Criteria:
- Moderate to severe allergic conjunctivitis
- Moderate to severe dry eyes
- Keratoconus or other related corneal irregularity
- Strabismus
- Amblyopia
- Nystagmus
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