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

Not Applicable

Active, not recruiting

• Conditions: Myopia, Progressive

• Registration Number: NCT06647160
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-15
• Study First Posted: 2024-10-17
• Study Start: 2024-11-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Primary Completion: 2026-12-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Changes of axial length (AL) at two years	2 years	The difference of AL (mm) at two years compared with baseline AL. AL will be measured by IOLMaster-700.
Visual scale score at two years	2 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).
Incidence of adverse event during study period	2 years	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.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China