MyopiaNCT03358862
Myopia Progression With a Novel Extended Depth of Focus Contact Lens
An observational study of Myopia and Myopia, Progressive, run by Aller, Thomas A., OD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Myopia, Progressive
- What is being tested?
- NaturalVue Multifocal Contact Lens
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 1 Jul 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Study population will be drawn from the clinic of the principal investigator.
Who may be able to join
- 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
Who cannot join
- Moderate to severe allergic conjunctivitis
- Moderate to severe dry eyes
- Keratoconus or other related corneal irregularity
- Strabismus
- Amblyopia
- Nystagmus
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Thomas Aller Optometrist, Inc.
San Bruno, California, 94066
About this study
Official title: 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.
Read more
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.
- Conditions
- Myopia, Myopia, Progressive
- Being tested
- NaturalVue Multifocal Contact Lens
- Keywords
- myopia, progressive myopia, contact lenses, extended depth of focus, retrospective clinical series, axial length, refractive error
- Medical subject headings
- Myopia, Myopia, Degenerative, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaturalVue Multifocal Contact LensDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NaturalVue Multifocal Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive error changes
Changes in myopia over time will be characterized by the spherical equivalent refractive error as measured by manifest subjective refraction.
Measured: 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
Measured: Data will be collected at baseline and at every six months.
Secondary outcomes (2)
Corneal curvature
Keratometry will be measured by the Zeiss IOLMaster
Measured: 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.
Measured: Data will be collected at baseline and at every six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Jan 2017
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Aller, Thomas A., OD
- Sponsor type
- University, hospital or other
- Collaborators
- Visioneering Technologies, Inc
- Responsible party
- Principal investigator, Thomas A. Aller, OD, Aller, Thomas A., OD
- Investigators
- Thomas A Aller, OD, Principal investigator, Independent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358862
- Sponsor's protocol ID
- SI-09-37
- Status last verified
- Jan 2021
- First submitted
- 26 Nov 2017
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 26784710Aller 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 24357844Aller 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.
PubMed 18601670Cooper 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 29053555Woods 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia Progression in Children and Adolescents Before and After Use of a Novel Extended Depth of Focus Daily Disposable Soft Contact Lens
- ClinicalTrials.gov ID
- NCT03358862
- Acronym / sponsor ID
- SI-09-37
- Conditions
- Myopia, Myopia, Progressive
- Keywords
- myopia, progressive myopia, contact lenses, extended depth of focus, retrospective clinical series, axial length, refractive error
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aller, Thomas A., ODUniversity, hospital or other
- Collaborators
- Visioneering Technologies, Inc
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myopes | – | Device: NaturalVue Multifocal Contact LensChildren, 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. |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study population will be drawn from the clinic of the principal investigator.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Moderate to severe allergic conjunctivitis
- Moderate to severe dry eyes
- Keratoconus or other related corneal irregularity
- Strabismus
- Amblyopia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaturalVue Multifocal Contact LensNaturalVue 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. | Device | Myopes |
Primary outcome
Refractive error changes
Time frame: Data will be collected at baseline and at every six months.
Changes in myopia over time will be characterized by the spherical equivalent refractive error as measured by manifest subjective refraction.
Axial length of the eye
Time frame: Data will be collected at baseline and at every six months.
Changes in the axial length of the eye will be measured with the Zeiss IOLMaster
2 secondary outcomes
Corneal curvature
Time frame: Data will be collected at baseline and at every six months
Vitreous Chamber Depth
Time frame: Data will be collected at baseline and at every six months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Background: PubMed 26784710Aller 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.
- Background: PubMed 24357844Aller TA. Clinical management of progressive myopia. Eye (Lond). 2014 Feb;28(2):147-53. doi: 10.1038/eye.2013.259. Epub 2013 Dec 20.
- Background: PubMed 18601670Aller 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.
- Background: PubMed 29053555Cooper 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.
- Background: PubMed 23471891Woods 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas A Aller, OD principal investigator
Independent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Myopia, Progressive, run by Aller, Thomas A., OD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refractive error changes (time frame: Data will be collected at baseline and at every six months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03358862, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.