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

NCT ID: NCT06647160

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2027-03-30

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.

Conditions

Myopia, Progressive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

Blue star MAX-5 spectacle lens

Group Type: EXPERIMENTAL

Blue star MAX-5 spectacle lens

Intervention Type: DEVICE

The children in the experimental group will wear Blue star MAX-5 spectacle lens and receive follow-up examinations every half year.

Control

Single-vision spectacle lens

Group Type: ACTIVE_COMPARATOR

Single-vision spectacle lens

Intervention Type: DEVICE

The children in the single-vision lenses group will wear single-vision spectacle lens and receive follow-up examinations every half year.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• 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.

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;

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Ge

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2024KYPJ115

Identifier Type: -

Identifier Source: org_study_id