NCT06717035

Evaluation of Performance of MiYOSMART Photochromic and Clear Spectacle Lenses in Myopic Children

Evaluation of Performance of MiYOSMART Photochromic and Clear Spectacle Lenses in Myopic Children.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: Singapore National Eye Centre · Other Government
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

This clinical study aims to evaluate the non-inferiority of the photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in myopia management.

Detailed description

Myopia now is recognized as one of the important public health problems and myopia prevention and control has become more important. Various myopia management strategies have been tested in the past for the control of myopia progression in children. In recent years, various optical interventions have also been explored to manage myopia, including the use of optical, pharmaceutical, and lifestyle interventions. Spectacles, atropine eye drops, and outdoor activities have shown some efficacy in slowing myopia progression, but the optimal approach to delaying or preventing the onset of myopia in at-risk populations remains a challenge. These myopia management modalities are often also labelled as invasive and non-invasive methods. One of the non-invasive myopia management modalities includes spectacles. DIMS spectacle lenses are based on creating myopic defocus at the mid-periphery of the retina which would provide a cue of axial length elongation control. DIMS is a spectacle lens with a central optical zone of 9.4 mm for correcting distance myopic refractive errors and a mid-peripheral 33mm of treatment zone with multiple segments of 1 mm diameter, each segment provides defocus of + 3.5D. 2-year Randomised Controlled Trial (RCT) showed 52% reduction in myopia progression and 62% slow down effect in axial elongation in children wearing DIMS spectacle lenses compared to those on single vision spectacle lens correction at the end of 2-year follow-up in Hong Kong children. 2-years RCT has been conducted using DIMS clear spectacle lenses, however, no studies have been conducted on photochromic and polarized version to show the non-inferiority of sun solutions compared to clear version in myopia management. This clinical study aims to evaluate the non-inferiority of the photochromic DIMS spectacles lenses performance (PDIMS) compared to clear DIMS spectacles lenses (DIMS) in myopia management.

Conditions

• Myopia
• Myopia Progression

Interventions

Type	Name	Description
DEVICE	EYE001	Defocus incorporated multiple segments (DIMS) clear vs DIMS photochromic

Timeline

• Start date: 2025-01-02
• Primary completion: 2027-01-02
• Completion: 2027-01-02
• First posted: 2024-12-04
• Last updated: 2024-12-04

Locations

1 site across 1 country: Singapore