NCT05740930

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

Effectiveness and Safety of Partition Multi-point Defocused Myopia Management Spectacle Lens in Myopia Control Compared With Spectacle Lenses With Aspherical Lenslets: a Randomised Non-inferiority Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 8 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Myopia

Interventions

Type	Name	Description
OTHER	Partition defocus myopia management spectacle lens	Participants in the intervention group will receive the partition defocus myopia management spectacles lens and receive follow-up checks.
OTHER	Spectacle lenses with aspherical lenslets	Participants in the control group will receive the spectacle lenses with aspherical lenslets and receive follow-up checks.

Timeline

• Start date: 2023-03-20
• Primary completion: 2025-05-27
• Completion: 2025-05-27
• First posted: 2023-02-23
• Last updated: 2026-03-12

Locations

1 site across 1 country: China