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

Zhongshan Ophthalmic Center, Sun Yat-sen University1 site in 1 country200 target enrollmentNovember 1, 2024

ConditionsMyopia, Progressive

InterventionsBlue star MAX-5 spectacle lens Single-vision spectacle lens

Overview

Phase: Not Applicable
Intervention: Blue star MAX-5 spectacle lens
Conditions: Myopia, Progressive
Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Enrollment: 200
Locations: 1
Primary Endpoint: Changes of spherical equivalent refraction (SER) at two years
Status: Active, not recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 1, 2024

End Date

March 30, 2027

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Responsible Party

Sponsor

Eligibility Criteria

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.