Myopia Progression With a Novel Extended Depth of Focus Contact Lens

NCT03358862 | Unknown DMC FDA Device

• 1 other identifier: SI-09-37
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Myopia, Progressive

Keywords

myopia; progressive myopia; contact lenses; extended depth of focus; retrospective clinical series; axial length; refractive error

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Corneal curvature

  Data will be collected at baseline and at every six months

• Vitreous Chamber Depth

  Data will be collected at baseline and at every six months.

Study Arms (1)

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

Interventions

NaturalVue Multifocal Contact Lens DEVICE

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.

Myopes

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Moderate to severe allergic conjunctivitis
• Moderate to severe dry eyes
• Keratoconus or other related corneal irregularity
• Strabismus
• Amblyopia
• Nystagmus

Sponsors & Collaborators

• Aller, Thomas A., OD: lead
• Visioneering Technologies, Inc: collaborator

Study Sites (1)

Dr. Thomas Aller Optometrist, Inc.

San Bruno, California, 94066, United States

Location

Related Publications (5)

• 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.

  PMID: 26784710 BACKGROUND

• 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.

  PMID: 24357844 BACKGROUND

• 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.

  PMID: 18601670 BACKGROUND

• 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.

  PMID: 29053555 BACKGROUND

• 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.

  PMID: 23471891 BACKGROUND

MeSH Terms

Conditions

Myopia; Myopia, Degenerative; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Thomas A Aller, OD

  Independent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2017
• First Posted: December 2, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)