NCT05740904

Efficacy and Safety of the New Defocus Spectacle Lens in Preventing Progression of Myopia

Efficacy and Safety of New Defocus Spectacle Lens in Preventing Progression of Myopia Compared With the Conventional Single-vision Spectacle Lens: a Randomized Controlled Trial Among Chinese Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

The clinical effects of new technical spectacles with refractive correction function are mixed. A randomised trial is designed to compare the effects of new defocusing spectacle lenses and traditional aspheric spectacle lenses on myopia progression in Chinese children aged 6-14 years.

Detailed description

Myopia has become the focus of global attention. There has been a lot of evidence that soft bifocal contact lenses, corneal plastic lenses, low-concentration atropine and outdoor time can reduce the incidence and progress of myopia, while the clinical effects of new technical spectacles with refractive correction function are mixed. Among the strategies of myopia control through optical intervention, the clinical researches of the bifocal spectacle lens showed that the myopia progression can be slowed by about 50% in two years. However, for active children, wearing 1.50D binoculars may increase the risk of injury caused by falls. Moreover, DIMS (Defocus Incorporated Multiple Segments) spectacle lens which also reported that myopia can be effectively controlled is the effect of reducing the far-sighted defocus of omnidirectional off-axis aberration. Although the DIMS lens do not have the discomfort of wearing like the bifocal lens, because several small defocusing areas divide the imaging, the field of vision will feel uncomfortable vibration, or feel scattered light, which will hinder the field of vision. Like DIMS lens, defocus spectacle lens aims to suppress hyperopia defocus caused by omni-directional off-axis aberration. The method is to set the focal depth extension area and optical center (refractive correction area) of astigmatism with relatively positive refractive power in the surrounding concentric circle area. The precise focusing position of astigmatism, that is, the defocusing amount of the forward refractive force as the equivalent spherical lens, is about 2.75D as the same as the DIMS lens. The change from the two straight focus lines in the front and back directions of astigmatism to the point image distribution of precise focus is very gentle, so there will be no sharp point image change like the DIMS lens, which can inhibit the discomfort of the field of vision being divided. This study plans to design a randomised trial to compare the effects of new defocusing spectacle lenses and traditional aspheric spectacle lenses on myopia progression in Chinese children aged 6-14 years.

Conditions

• Myopia

Interventions

Type	Name	Description
OTHER	New defocus spectacle lenses	The children in the new defocus spectacle lens group will wear new defocus spectacle and receive follow-up examinations every half year.
OTHER	Convenional aspheric single-vision spectacle lenses	The children in the convenional aspheric spectacle lenses group will wear conventional aspheric single-vision spectacle and receive follow-up examinations every half year.

Timeline

• Start date: 2023-03-23
• Primary completion: 2024-04-22
• Completion: 2024-04-22
• First posted: 2023-02-23
• Last updated: 2025-01-23

Locations

1 site across 1 country: China