Can Distance Center and Near Center Multifocal Contact Lenses Control Myopia Progression in Children?
Public ClinicalTrials.gov record NCT03519490. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Myopia Progression in Children Wearing Near Center and Distance Center Multifocals - a Randomized Controlled Clinical Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03519490
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 7 Years to 14 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2018
- Primary completion
- Jul 30, 2020
- Completion
- Aug 30, 2020
- Last update posted
- Jul 4, 2019
2018 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dr. Thomas Aller Optometrist, Inc. | San Bruno | California | 94066 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03519490, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 4, 2019 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03519490 live on ClinicalTrials.gov.