NCT06563700

Novel Lenses for Myopia Progression Trial

A Double Masked, Randomised, Longitudinal Comparative Study to Evaluate the Myopia Progression of Novel Spectacle Lenses Versus Single Vision Spectacle Lenses in Children With Myopia

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 7 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center , prospective, randomised, longitudinal study to evaluate rate of myopia progression with novel lenses compared to Single-Vision spectacles. A total of 342 children will be recruited where 57 participants each are randomised to wear one of 5 test spectacle lens designs or a single vision lens (control) for 12 months. At the end of 12 months, those randomised to single vision lenses will be transferred to one of the test lenses and all the groups continued for another 12 months. Myopia progression during the second year with test lenses will be compared to historical or published controls.

Conditions

• Myopia, Progressive

Interventions

Type	Name	Description
OTHER	spectacle lens	one of ZEISS BD spectacle lens designs 1 to 5
OTHER	single vision lens	single vision lens

Timeline

• Start date: 2024-08-16
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2024-08-21
• Last updated: 2025-12-03

Locations

1 site across 1 country: China