ClinicalTrials.gg
Status unknownNCT03358862Updated Jan 12, 2021

Myopia Progression With a Novel Extended Depth of Focus Contact Lens

An observational study in Myopia and Myopia, Progressive, sponsored by Aller, Thomas A., OD. Status unknown at 1 site in United States. Open to participants aged 5 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-12.

Sponsored by Aller, Thomas A., OD · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
80
Ages
5 Years to 25 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 342 studies in Myopia with a site in United States — 27 open to participants now, 44 under way, 3 of them phase 3. Myopia · United States.

Planned enrollment
24th of 46
80 · median 91
Started
2017
with 15 others
Observational
48 of 342
6 open now
Registered
163rd of 342
by date

Among the 342 studies in Myopia with a site in United States, this one is the 24th largest by planned enrollment of the 46 observational ones that give a count, is one of 16 that started in 2017, is one of 48 observational ones, and was the 163rd registered.

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

Browse Myopia studies →

Open to participants now

27 of the 342 studies in Myopia with a site in United States are open now. Recruiting first, the newest first:

22 more — sign in →

All 27 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 122 Myopia studies recruiting now, 19 (16%) set no upper age limit and 102 (84%) stop at 75 or younger; 86 take children under 18; 53 take healthy volunteers.

This study: 5 Years to 25 Years · all sexes · healthy volunteers too.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Myopia
  • Myopia, Progressive

Keywords

  • myopia
  • progressive myopia
  • contact lenses
  • extended depth of focus
  • retrospective clinical series
  • axial length
  • refractive error
04

Who can participate

Ages eligible
5 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Moderate to severe allergic conjunctivitis
  • Moderate to severe dry eyes
  • Keratoconus or other related corneal irregularity
  • Strabismus
  • Amblyopia
  • Nystagmus
05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
80 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • DeviceNaturalVue 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.

06

What researchers measure

Primary outcomes

  1. Refractive error changes

    Changes in myopia over time will be characterized by the spherical equivalent refractive error as measured by manifest subjective refraction.

    Time frame: Data will be collected at baseline and at every six months.

  2. Axial length of the eye

    Changes in the axial length of the eye will be measured with the Zeiss IOLMaster

    Time frame: Data will be collected at baseline and at every six months.

Secondary outcomes

  1. Corneal curvature

    Keratometry will be measured by the Zeiss IOLMaster

    Time frame: Data will be collected at baseline and at every six months

  2. 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.

    Time frame: Data will be collected at baseline and at every six months.

07

Study locations

1 site
  • Dr. Thomas Aller Optometrist, Inc.
    San Bruno, California 94066, United States
08

References and documents

Publications

  • 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. PubMed 26784710 ↗
  • 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. PubMed 24357844 ↗
  • 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. PubMed 18601670 ↗
  • 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. PubMed 29053555 ↗
  • 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. PubMed 23471891 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2017 (actual). Primary completion is estimated for Jan 2022, 60 months after the start.

Of 87 non-industry observational studies under Myopia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 90. This study's planned 60 months is above that.

Counting every sponsor, half of 96 studies reached it within 24 months; a quarter within 10 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2017
First posted
Dec 2, 2017
StartActual
Jan 1, 2017
Primary completionEst.
Jan 1, 2022
CompletionEst.
Jul 1, 2022
Last update
Jan 12, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03358862
Lead sponsor
Aller, Thomas A., OD
Collaborators
Visioneering Technologies, Inc
Responsible party
Thomas A. Aller, OD (Principal Investigator, Aller, Thomas A., OD) — Principal investigator
First posted
Dec 2, 2017
Start date
Jan 1, 2017
Primary completion
Jan 1, 2022 (estimated)
Completion
Jul 1, 2022 (estimated)
Last update
Jan 12, 2021

Study contacts

Thomas A Aller, OD
principal investigator · Independent

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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