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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia, Progressive
• Intervention / Treatment: Device: Blue star MAX-5 spectacle lens; Device: Single-vision spectacle lens

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 8 to 11 years;
• Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -6.00 to -0.50 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D;
• Best-corrected visual acuity of equal or better than 0.00 LogMAR (>= 1.0 as Snellen).
• The intraocular pressure of 10 to 21mmHg.
• Volunteer to participate in this clinical trial with signature of the informed consent form.

Exclusion Criteria:

• History of eye injury or intraocular surgery;
• Clinically abnormal slit-lamp findings
• Abnormal fundus examination
• Ocular disease, such as uveitis and other inflammatory diseases, glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function;
• Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);
• Participation of the drug clinical trial within three month and the device clinical trial within one month;
• Only one eye meets the inclusion criteria;
• Unable to have regular follow-up
• Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursingproducts), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Blue star MAX-5 spectacle lens	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.
Active Comparator: Control; Single-vision spectacle lens	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of spherical equivalent refraction (SER) at two years	The difference of SER (Diopter) at two years compared with baseline SER. SER will be measured after cycloplegia.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of axial length (AL) at two years	The difference of AL (mm) at two years compared with baseline AL. AL will be measured by IOLMaster-700.	2 years
Visual scale score at two years	Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2) is scaled from 0 (poor quality of life) to 100 (good quality of life).	2 years
Incidence of adverse event during study period	Adverse event is a comprehensive qualitative outcome measure that will be evaluated based on the participants' symptoms and signs, intraocular pressure, slit lamp and fundus examinations, as well as lens and frame damage. The evaluation will be conducted every six months according to the predetermined definition of abnormalities in the above examinations.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of lens thickness (LT) at two years	The difference of LT (mm) at two years compared with baseline LT. LT will be measured by IOLMaster-700.	2 years
Change of corneal power (CP) at two years	The difference of CP (diopter) at two years compared with baseline CP. CP will be measured by IOLMaster-700.	2 years
Best corrected visual acuity at two years	Best corrected visual acuity will be measured at baseline and two years by EDTRS visual acuity chart.	2 years
Binocular visual function at two years	Binocular visual function which is a qualitative outcome assessed by a series of tests will be measured every half year.	2 years
Change of choroidal thickness at two years	The difference of Choroidal thickness (μm) at two years compared with baseline measure. Choroidal thickness will be measured by OCTA.	2 years

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Investigators: Principal Investigator: Jian Ge, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Myopia control; concentric columnar microstructure
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative
• Other Study ID Numbers: 2024KYPJ115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No