Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
Study NCT ID:
NCT05888792
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2023-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes
Sponsor:
The Hong Kong Polytechnic University
Organization:
Study Overview
Official Title:
Myopia Control Effectiveness of Second-generation Defocus Incorporated Multiple Segments Spectacle Lenses on Fast Progressing Myopes: A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-01
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 (D2) 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 (D2) group (treatment). After 12 months of lens wear, the SV lens prescribed to the control group will be replaced with the D2 lens and be monitored for another 12 months. In parallel, the D2 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 (D2) group (treatment). After 12 months of lens wear, the SV lens prescribed to the control group will be replaced with the D2 lens and be monitored for another 12 months. In parallel, the D2 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:
True
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?:
False
Is an FDA AA801 Violation?: