Myopia Progression With a Novel Extended Depth of Focus Contact Lens

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.

Study Overview

• Status: Unknown
• Conditions: Myopia; Myopia, Progressive
• Intervention / Treatment: Device: NaturalVue Multifocal Contact Lens

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• United States
  • California
    • San Bruno, California, United States, 94066
      • Dr. Thomas Aller Optometrist, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population will be drawn from the clinic of the principal investigator.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Myopes; Children, adolescents and young adults with existing progressive myopia equal to or exceeding -0.50 D in the year prior to beginning the use of the NaturalVue contact lens.	Device: NaturalVue Multifocal Contact Lens; NaturalVue multifocal contact lenses are daily disposable, distance center, multifocals with a novel extended depth of focus optical design. Patients wearing their habitual corrections who opt to change to this new lens will have their myopia progression monitored for up to two years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refractive error changes	Changes in myopia over time will be characterized by the spherical equivalent refractive error as measured by manifest subjective refraction.	Data will be collected at baseline and at every six months.
Axial length of the eye	Changes in the axial length of the eye will be measured with the Zeiss IOLMaster	Data will be collected at baseline and at every six months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal curvature	Keratometry will be measured by the Zeiss IOLMaster	Data will be collected at baseline and at every six months
Vitreous Chamber Depth	Vitreous Chamber Depth will be derived from measures of the Anterior Chamber Depth and the axial length as measured by the Zeiss IOLMaster.	Data will be collected at baseline and at every six months.

Collaborators and Investigators

• Sponsor: Aller, Thomas A., OD
• Collaborators: Visioneering Technologies, Inc
• Investigators: Principal Investigator: Thomas A Aller, OD, Independent

Publications and helpful links

General Publications

• 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.
• 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. Clinical management of progressive myopia. Eye (Lond). 2014 Feb;28(2):147-53. doi: 10.1038/eye.2013.259. Epub 2013 Dec 20.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: November 26, 2017
• First Submitted That Met QC Criteria: November 26, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: contact lenses; axial length; myopia; refractive error; extended depth of focus; progressive myopia; retrospective clinical series
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative
• Other Study ID Numbers: SI-09-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No