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

Sun Yat-sen University

Status: Active, not recruiting

Conditions: Myopia, Progressive

Treatments: Device: Single-vision spectacle lens; Device: Blue star MAX-5 spectacle lens

Study type: Interventional

Funder types: Other

Identifiers

NCT06647160

2024KYPJ115

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 8 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Intervention

Experimental group

Description:

Blue star MAX-5 spectacle lens

Treatment:

Device: Blue star MAX-5 spectacle lens

Control

Active Comparator group

Description:

Single-vision spectacle lens

Treatment:

Device: Single-vision spectacle lens