Can Distance Center and Near Center Multifocal Contact Lenses Control Myopia Progression in Children?

Withdrawn before enrolling · Not applicable

Conditions studied: Myopia, Myopia, Progressive

In brief

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.

Key facts

Study ID

NCT03519490

Run by

Thomas A. Aller, OD

People needed

0

Starts

2018-06-01

Expected to finish

2020-08-31

Last updated by the study team

2019-07-05

Who can join

Age: 7 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dr. Thomas Aller Optometrist, Inc. — San Bruno, California, United States

Full record on ClinicalTrials.gov

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