Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07394556

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

Sponsor: Indizen Optical Technologies, S.L.U.

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2026-04

Completion Date

2028-10

Last Updated

2026-03-05

Healthy Volunteers

Yes

Interventions

OTHER

myopia control lens

Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.

Locations (3)

Universidade Do Minho

Braga, Portugal

Hospital Universitario Clínico San Carlos

Madrid, Spain

Ulster University

Coleraine, United Kingdom