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ACTIVE NOT RECRUITING
NCT06647160
NA

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

Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

8 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-11-01

Completion Date

2027-03-30

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

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.

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China