An interventional study of MYOFIX FULL FIELD PERIPHERAL DEFOCUS SPECTACLE in Myopia Progression, sponsored by Novar Corporation. Completed at 1 site in Argentina. Open to participants aged 7 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by Novar Corporation · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and tolerability of the use of a new model of spectacles designed to control the progression of myopia in childhood. School myopia in children is mainly produced by increased ocular growth. This new spectacle design is based in the fact that positive lenses in front of eyes produce changes that decrease ocular growth. It consists of a full field peripheral positive defocus lens and a central section for the distance correction. The study is designed to evaluate tolerance and efficacy of this new lens in myopic children along a two year period.
The Myofix Defocus Study is a longitudinal, prospective, interventional, non-randomized research study intended to evaluate the tolerability and effectiveness of the use of spectacles with special design to control the progression of myopia during childhood. This field study included children aged 8 to 15 years old who voluntarily agreed to use the Defocus Spectacles for one year. A pair of spectacles (Myofix, Novar, Argentina) with frames (Usual, Argentina) were provided free of charge to all children studied for one year with the special addendum of peripheral defocus treatment. Children are instructed to wear the glasses the whole day every day of the week including Saturdays and Sundays.The Argentinian Defocus Spectacle lens design preserves the principle of the original design presented by Carly Lam et al., which consisted of a 9 mm central zone for distance correction and a +3.50 diopters defocus correction ring of lenslets laying between 9 and 32 mm diameter to act primarily on the para foveal zone that detects the defocus that governs the growth of the eye. Instead of micro peripheral defocus lenses in the 32 mm diameter ring zone with treatment, our model has a uniform peripheral +/+3.50 diopters power zone add. As it is known that 30-40 minutes of exposure to myopic defocus modifies the axial length (measured with Lenstar) by approximately 10-15 microns due to changes in choroidal thickness, the national design has been tested on 17 volunteer subjects showing a significant change of 11 microns shortening in the axial length of their eyes, such that that pilot study suggested the lenses could be effective in arresting the progression of myopia, as changes in the choroid are the first events in the retinal message that manages ocular growth. For comparing the outcomes of this study two virtual control groups in American children will be considered. One control group will be taken from a study in US giving children diluted atropine drops for myopia control. The placebo treated arm of this group will be considered. The other control group will be a cohort of children followed up in Argentina with cycloplegic refractions one year before the pandemic closeup began.
This is the only study on the registry with Novar Corporation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MYOPIC CHILDREN TREATED WITH MYOFIX SPECTACLES
Device: MYOFIX FULL FIELD PERIPHERAL DEFOCUS SPECTACLE
This is a plus peripheral add spectacle with the central part for the myopic correction.
RATE OF MYOPIA PROGRESSION IN DIOPTERS
THE AMOUNT OF DIOPTERS OF MYOPIC PROGRESSION IN ONE YEAR FOLLOW UP MEASURED WITH CYCLOPLEGIC REFRACTIONS
Time frame: 12 MONTHS AND 24 MONTHS FOLLOW UP PLANNED
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — There are plans to share individual participant data if any investigator in the area of myopia control research asks us about the data.
Supporting information: Study protocol, Sap
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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