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Not listed No phase listed Observational Accepts healthy volunteers

Myopia Progression With a Novel Extended Depth of Focus Contact Lens

ClinicalTrials.gov ID: NCT03358862

Public ClinicalTrials.gov record NCT03358862. 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.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 9:12 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Myopia Progression in Children and Adolescents Before and After Use of a Novel Extended Depth of Focus Daily Disposable Soft Contact Lens

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 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.

Study identification

NCT ID
NCT03358862
Recruitment status
Not listed
Study type
Observational
Phase
Not listed
Lead sponsor
Aller, Thomas A., OD
Other
Enrollment
80 participants

Conditions and interventions

Eligibility (public fields only)

Age range
5 Years to 25 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
Dec 31, 2016
Primary completion
Dec 31, 2021
Completion
Jun 30, 2022
Last update posted
Jan 11, 2021

2017 – 2022

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 NCT03358862, 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 Jan 11, 2021 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03358862 live on ClinicalTrials.gov.

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