NCT06857864

Exploratory Study on the Effectiveness of Myopia Control Lenses in Slowing Myopia Progression in Young Children

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Essilor International · Industry
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Accepted

Summary

This study will be a mono-center, single-arm, unmasked study evaluating the effectiveness of test lens in slowing myopia progression in children aged 6 to 8 years. The study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lens over a 1-year period. A total of 25 children will be recruited.

Detailed description

As myopia has become a global epidemic and public health concern, it is crucial to gain deeper insight to the possible treatments in slowing myopia progression. In a previous clinical trial, spectacle lenses with higher lenlets asphericity demonstrated effectiveness in reducing myopia progression and axial length elongation in children. This clinical trial will assess the effectiveness of a test lens in slowing myopia progression in younger children over 1 year. Without compromising vision, the test lens is designed to modify the area and the amount of myopia defocus on the retina. The study population includes 25 children subjects in Singapore, aged 6 to 8 years during the commencement of the treatment. The axial length and spherical equivalent refraction will be the primary and secondary measures for myopia progression.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Test myopia control lenses (BSL)	Test spectacle lenses will be provided to the subjects throughout the 1 year clinical trial.

Timeline

• Start date: 2025-03-17
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-03-04
• Last updated: 2025-07-20

Locations

1 site across 1 country: Singapore