Prospective Research on the Intervention of Myoless2.0 Effectiveness (PRIME) in Pediatric Population

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

NCT Number	NCT07394556
Lead Sponsor	Indizen Optical Technologies, S.L.U. Collaborators: Hospital San Carlos, Madrid, University of Minho, University of Ulster
Conditions	Myopia Progression
Enrollment	180 participants
Start Date	2026-04
Primary Completion	2027-04 (estimated)
Study Completion	2028-10 (estimated)
Updated on ClinicalTrials.gov	2026-03-05