Myopia Clinical Trial
— ADPADPOfficial title:
Myopia Progression in Children Wearing Near Center and Distance Center Multifocals - a Randomized Controlled Clinical Trial
NCT number | NCT03519490 |
Other study ID # | SY-001001 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | August 31, 2020 |
Verified date | July 2019 |
Source | Aller, Thomas A., OD |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Myopia has been increasing in prevalence and severity throughout the world over the last 30
years. Increasing levels of myopia are associated with increased frequency and severity of
various ocular pathologies. Slowing myopia progression may help to reduce the future risks of
these ocular pathologies.
Conventional spectacles and contact lenses correct myopia by moving the central focus of the
eye from in front of the retina to on the retina centrally. 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 (MFCLs) and orthokeratology can
control myopia progression is that they 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.
It is possible that one of the mechanisms responsible for myopia progression control with
MFCLs is that when the eye is exposed to an image focused on the retina and simultaneously an
image anterior to the retina, that this will suppress axial elongation and myopia
progression. This mechanism would not be dependent on whether the anterior image is located
in the central area of the retina or the peripheral area of the retina. While there are no
published human studies demonstrating the effectiveness of near center MFCLs, this author has
presented retrospective data showing no differences in myopia progression between near center
and distance center MFCLs.
Synergeyes, Inc.'s Duette contact lenses are hybrids of rigid gas permeable (RGP) with a
silicon hydrogel peripheral portion or "skirt." They now make their MFCLs in both distance
center (DC) and near center (NC) designs.
This study will analyze the myopia progression of children after being randomly assigned to
wear Duette MFCLs or Duette standard single vision contact lenses over a span of two years.
Subjects assigned to the MFCL group will wear a DC lens on one eye and a NC lens on the other
and will reverse this lens assignment every six months. Refractive changes will be measured
by cycloplegic autorefraction and axial lengths will be measured with a laser interference
biometer (Zeiss IOLMaster) at six-month intervals.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 31, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 14 Years |
Eligibility |
Inclusion Criteria: - Myopia: = 0.5 D in least myopic meridian, < 12.0 D in most myopic meridian); - Anisometropia (interocular difference in refractive error) = 2D - Astigmatism: = 3D - Myopia progression = 0.5D in at least one eye based on available clinical records or based on habitual spectacle prescription - Visual acuity: best corrected acuity of 20/20 or better in each eye - Capable of proper handling, insertion and removal of hybrid contact lenses Exclusion Criteria: - Ocular health: any pathology that may alter eye growth (e.g. history of retinal detachment & treatment for the same), and/or may adversely impact contact lens wear (e.g. chronic, poorly controlled allergic conjunctivitis) will be grounds for exclusion; - Strabismus, amblyopia - Systemic disease that may affect vision, vision development or contact lens wear - Chronic use of medications that may affect immunity, such as oral or topical corticosteroids - rigid or hybrid contact lens wear within the preceding 3 months; - prior ocular surgery, - nursing or pregnant mothers - participants who cannot commit to the 24 month study period or who have a high likelihood of leaving the area within the 24 month study period |
Country | Name | City | State |
---|---|---|---|
United States | Dr. Thomas Aller Optometrist, Inc. | San Bruno | California |
Lead Sponsor | Collaborator |
---|---|
Thomas A. Aller, OD | SynergEyes, Inc. |
United States,
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* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Myopia progression rate | Change in myopia over time, expressed in terms of an annualized rate, based on cycloplegic spherical equivalent refractive error as measured by autorefraction. | Data will be collected at baseline, that is to say at the beginning of the 24 month study, and also at six months after baseline, at 12 months, at 18 months and at study completion or 24 months. | |
Primary | Axial elongation rate | Change in axial length over time, expressed in terms of an annualized rate, based on measurement with the Zeiss IOLMaster. | Data will be collected at baseline, that is to say at the beginning of the 24 month study, and also at six months after baseline, at 12 months, at 18 months and at study completion or 24 months. | |
Secondary | Subjective myopia progression rate | Change in myopia over time, expressed in terms of an annualized rate, based on cycloplegic spherical equivalent refractive error as measured by subjective refraction. | Data will be collected at baseline, that is to say at the beginning of the 24 month study, and also at six months after baseline, at 12 months, at 18 months and at study completion or 24 months. | |
Secondary | Macular Pigment Optical Density | Macular pigment optical density is measured by the QuantifEye device. | Data will be collected at baseline and at 24 months from baseline at study completion. | |
Secondary | Tear Film Dynamics and Meibomian Gland Health | Lipid layer thickness, blink dynamics and meibomian gland health will be assessed with the Tear Science (Johnson & Johnson) Lipiview device. | Data will be collected at baseline and at 24 months from baseline at study completion. |
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