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
Indizen Optical Technologies, S.L.U.
Lead sponsor
Hospital San Carlos, Madrid
Collaborator
University of Minho
Collaborator
University of Ulster
Collaborator