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

NCT06647160 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jian Ge · Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-12-30
Completion
2027-03-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06647160 on ClinicalTrials.gov