Clinical trial NCT03358862: Myopia Progression With a Novel Extended Depth of Focus Contact Lens
Official title: Myopia Progression in Children and Adolescents Before and After Use of a Novel Extended Depth of Focus Daily Disposable Soft Contact Lens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Myopia, Progressive
Keywords: myopia
progressive myopia
contact lenses
extended depth of focus
retrospective clinical series
axial length
refractive error
Lead sponsor: Aller, Thomas A., OD
Sponsor class: OTHER
Collaborators: name: Visioneering Technologies, Inc
First posted: 2017-12-02
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be drawn from the clinic of the principal investigator.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Refractive error changes
timeFrame: Data will be collected at baseline and at every six months.
measure: Axial length of the eye
timeFrame: Data will be collected at baseline and at every six months.
Secondary outcomes:
measure: Corneal curvature
timeFrame: Data will be collected at baseline and at every six months
measure: Vitreous Chamber Depth
timeFrame: Data will be collected at baseline and at every six months.
Other outcomes:
Locations:
city: San Bruno
country: United States
facility: Dr. Thomas Aller Optometrist, Inc.
state: California
Study officials:
affiliation: Independent
name: Thomas A Aller, OD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aller TA, Liu M, Wildsoet CF. Myopia Control with Bifocal Contact Lenses: A Randomized Clinical Trial. Optom Vis Sci. 2016 Apr;93(4):344-52. doi: 10.1097/OPX.0000000000000808.
citation: Aller TA. Clinical management of progressive myopia. Eye (Lond). 2014 Feb;28(2):147-53. doi: 10.1038/eye.2013.259. Epub 2013 Dec 20.
citation: 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.
citation: Cooper J, O'Connor B, Watanabe R, Fuerst R, Berger S, Eisenberg N, Dillehay SM. Case Series Analysis of Myopic Progression Control With a Unique Extended Depth of Focus Multifocal Contact Lens. Eye Contact Lens. 2018 Sep;44(5):e16-e24. doi: 10.1097/ICL.0000000000000440.
citation: Woods J, Guthrie SE, Keir N, Dillehay S, Tyson M, Griffin R, Choh V, Fonn D, Jones L, Irving E. Inhibition of defocus-induced myopia in chickens. Invest Ophthalmol Vis Sci. 2013 Apr 12;54(4):2662-8. doi: 10.1167/iovs.12-10742.