Zhongshan Ophthalmic Center, Sun Yat-sen University
Phase
Not applicable
Started
2024-11-01
Last updated
2026-03-12
Condition(s) studied
Myopia, Progressive
Investigational drug(s) / intervention(s)
Blue star MAX-5 spectacle lensSingle-vision spectacle lens
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.
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.
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.
Eligibility
Sex
ALL
Min age
8 Years
Max age
11 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Changes of spherical equivalent refraction (SER) at two years — 2 years The difference of SER (Diopter) at two years compared with baseline SER. SER will be measured after cycloplegia.
Trial sites (1)
Facility
City
Region
Status
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou
Guangdong
More Zhongshan Ophthalmic Center, Sun Yat-sen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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