Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05740904
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2023-02-13
Brief Title:
Efficacy and Safety of the New Defocus Spectacle Lens in Preventing Progression of Myopia
Sponsor:
Zhongshan Ophthalmic Center Sun Yat-sen University
Organization:
Zhongshan Ophthalmic Center Sun Yat-sen University
Study Overview
Official Title:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 150D 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 275D 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
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 150D 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 275D 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None