NCT06647160

Safety and Efficacy of Blue Star MAX-5 Lenses in Myopia Control

Safety and Efficacy of Blue Star MAX-5 Lenses in Mvopia Control: A Randomized Controlled Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 8 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomised controlled clinical trial is to compare the effects of a new type of concentric columnar microstructure lens and single-vision spectacle lenses on myopia progression in Chinese children aged 8-11 years with refractive error ranging from -0.50D to -6.00D. Participants will wear spectacles and receive follow-up examinations every half year.

Conditions

• Myopia, Progressive

Interventions

Type	Name	Description
DEVICE	Blue star MAX-5 spectacle lens	The children in the experimental group will wear Blue star MAX-5 spectacle lens and receive follow-up examinations every half year.
DEVICE	Single-vision spectacle lens	The children in the single-vision lenses group will wear single-vision spectacle lens and receive follow-up examinations every half year.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-12-30
• Completion: 2027-03-30
• First posted: 2024-10-17
• Last updated: 2026-03-12

Locations

1 site across 1 country: China