Myopia Clinical Trial
Official title:
Myopia Progression in Children and Adolescents Before and After Use of a Novel Extended Depth of Focus Daily Disposable Soft Contact Lens
Verified date | January 2021 |
Source | Aller, Thomas A., OD |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | July 1, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 25 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dr. Thomas Aller Optometrist, Inc. | San Bruno | California |
Lead Sponsor | Collaborator |
---|---|
Aller, Thomas A., OD | Visioneering Technologies, Inc. |
United States,
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. — View 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. Erratum in: Clin Exp Optom. 2008 Sep;91(5):479. — View 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. Review. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | Corneal curvature | Keratometry will be measured by the Zeiss IOLMaster | Data will be collected at baseline and at every six months | |
Secondary | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04923841 -
Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine
|
N/A | |
Active, not recruiting |
NCT04080128 -
Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control
|
N/A | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Completed |
NCT04604405 -
Effects of 650nm Low Energy Light on Human Retina and Choroid Microcirculation
|
N/A | |
Recruiting |
NCT05594719 -
The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow
|
N/A | |
Completed |
NCT05594732 -
The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow
|
N/A | |
Completed |
NCT04492397 -
Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
|
N/A | |
Completed |
NCT04536571 -
Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses
|
N/A | |
Completed |
NCT06046209 -
Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens
|
N/A | |
Recruiting |
NCT06344572 -
Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia
|
Phase 3 | |
Recruiting |
NCT05611294 -
Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction
|
N/A | |
Completed |
NCT05656885 -
Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses
|
N/A | |
Active, not recruiting |
NCT05534022 -
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression.
|
N/A | |
Completed |
NCT03934788 -
the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens
|
N/A | |
Completed |
NCT03701516 -
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2
|
N/A | |
Completed |
NCT05538754 -
Post-Market Evaluation of the EVO ICL
|
N/A | |
Completed |
NCT03139201 -
Clinical Performance of the OxyAqua Daily Disposable Silicone Hydrogel Soft Contact Lens
|
N/A | |
Completed |
NCT02555722 -
Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear
|
N/A | |
Not yet recruiting |
NCT06009458 -
Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
|
N/A | |
Recruiting |
NCT05548478 -
Corneal Endothelial Cell Injury Induced by Mitomycin-C
|
N/A |