Effectiveness and Safety of Partition Multi-point Defocused Myopia Management Spectacle Lens in Myopia Control

Sun Yat-sen University

Status: Active, not recruiting

Conditions: Myopia

Treatments: Other: Spectacle lenses with aspherical lenslets; Other: Partition defocus myopia management spectacle lens

Study type: Interventional

Funder types: Other

Identifiers

NCT05740930

2023KYPJ004

Details and patient eligibility

About

Myopia is considered to be the most common type of refractive error, and the incidence of myopia has shown a trend of low age. Recent studies found that the new aspheric microlens spectacle lens can more effectively control the progress of diopter than the single-vision spectcale lens. A new technology of equivalent defocusing around the lens called the partition multi-point defocus optical technology is adopted in this study.

Full description

Myopia is considered to be the most common type of refractive error, and it has increased rapidly worldwide. The vision damage caused by uncorrected myopia seriously affects the quality of life, may lead to poor academic performance of children, and cause considerable economic burden. About 90% of vision damage caused by myopia can be prevented by cost-effective interventions or treatment.

In recent years, the incidence of myopia has shown a trend of low age. Therefore, clinical intervention should be carried out in the childhood stage, which is the key period of eye development, to control the progress of myopia. A recent 2-year randomized controlled study in China found that the new aspheric microlens myopia control spectacle lens can more effectively control the progress of diopter than the single-vision spectcale lens. Different studies have found or proved the technical principle of the new aspheric defocusing microlens.

Animal experiments found that the direction, intensity and regional distribution of optical defocus signals have a substantial impact on the growth of eyes; The diopter of peripheral relative hyperopia can affect the central myopia; The changes of myopia and optical defocus in the nasal and temporal regions can change the shape and peripheral refraction of the eyes; Local changes in the effective focus of the eye will lead to regional changes in eye growth and refractive error. Based on the findings of animal experiments, the new technology of equivalent defocusing around the lens called the partition multi-point defocus optical technology is adopted in this study.

A prospective, single-center, open-label, non-inferiority randomized controlled trial is developed to evaluate the effectiveness and safety of partition multi-point defocused myopia management spectacle lens among children in China in myopia control.

Enrollment: 194 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 8 to 13 years;
• Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -0.75 to -4.75 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.00 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 nursing products), 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: Double Blind

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194 participants in 2 patient groups

Intervention group

Experimental group

Description:

The participants wear the partition defocus myopia management spectacle lens.

Treatment:

Other: Partition defocus myopia management spectacle lens

Control group

Active Comparator group

Description:

spectacle lenses with aspherical lenslets

Treatment:

Other: Spectacle lenses with aspherical lenslets