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
Study Type
OBSERVATIONAL
Enrollment
180
Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.
Universidade Do Minho
Braga, Portugal
Hospital Universitario Clínico San Carlos
Madrid, Spain
Ulster University
Coleraine, United Kingdom
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. Myopia progression is also expressed as the change in axial length from baseline levels. Myopia progression is characterized by ocular anatomical changes, the most notable being increased axial length.
Time frame: At baseline, 3, 6, 12, 18 and 24 months
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