Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05888792
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-05-24
Brief Title:
Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope A Randomised Control Trial
Status:
RECRUITING
Status Verified Date:
2023-06
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 purpose of this study is to examine the efficacy and performance of the variant of Defocus Incorporated Spectacle lenses on controlling myopia progression in fast progressing myopic children
Detailed Description:
The variant of Defocus Incorporated Spectacle lenses DG2 is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time
Participants will be randomly allocated to either single vision lens group control or the variant of Defocus Incorporated Spectacle lens DG2 group treatment After 12 months of lens wear the SV lens prescribed to the control group will be replaced with the DG2 lens and be monitored for another 12 months In parallel the DG2 treatment groups will continue their corresponding intervention for 12 months Their cycloplegic refraction and axial length will be monitored every 6 months over 2 years The changes in refractive errors and axial length in two groups will be compared
Participants will be randomly allocated to either single vision lens group control or the variant of Defocus Incorporated Spectacle lens DG2 group treatment After 12 months of lens wear the SV lens prescribed to the control group will be replaced with the DG2 lens and be monitored for another 12 months In parallel the DG2 treatment groups will continue their corresponding intervention for 12 months Their cycloplegic refraction and axial length will be monitored every 6 months over 2 years The changes in refractive errors and axial length in two groups will be compared
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