The Goal of the study is to evaluate the rate of myopia progression with open ring myopia control spectacle lens designs compared to a commercial peripheral plus myopia control spectacle lens (CML) in European children with myopia. This is a prospective, randomized, bilateral wear, double masked, cross-over clinical trial. There will be a total of 180 participants randomized into three groups, Group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (CML).
Group 2 - 60 participants will wear the Open Ring 1 (OR1) lens design. Group 3 - 60 participants will wear the Open Ring 2 (OR2) lens design. For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old. All groups will be required to wear spectacles for all waking hours for 12 months. After 12 months, the control group will continue wearing CML for a further 12 months; the Group 2 participants will continue wearing the OR1 lens for a further 12 months. The Group 3 participants will wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months
Be aged between 6 to 12 completed years (6 and 12 years inclusive), irrespective of gender.
For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old.
Be cycloplegic autorefraction spherical component -0.50 D to -6.00D, cylinder no more than -2.00D, and with a spherical equivalent greater than or equal to -6.00D.
Be accompanied by parents/guardians who can read and comprehend give informed consent as demonstrated by signing a record of informed consent.
A known allergy to, or a history of intolerance to cyclopentolate or topical anesthetics.
Had strabismus and/or amblyopia.
Cylinder more than -2.00D
Anisometropia greater than 1.50D spherical equivalent
Children aged between 6-12 years old from Spain, Portugal and the United Kingdom
Cohort
Prospective
myopia control lens
Other interventionEvaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.
Myopic progression in one year
This is expressed as the change in spherical equivalent refractive state from baseline levels. Spherical equivalent refraction will be taken as the mean of the spherical equivalent refraction of five, reliable, cycloplegic autorefraction measurements on each eye with a precision of 0.12D, measured in diopters (D). Myopia progression is also expressed as the change in axial length from baseline levels, measured in millimeters (mm). Myopia progression is characterized by ocular anatomical changes, the most notable being increased axial length, measured in millimeters (mm).
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Indizen Optical Technologies, S.L.U.
Lead sponsor
Hospital San Carlos, Madrid
Collaborator
University of Minho
Collaborator
University of Ulster
Collaborator
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