Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05134935
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2021-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Children Aged 6-12 Years.
Sponsor:
Vejle Hospital
Organization:
Study Overview
Official Title:
Defocus Incorporated Multiple Segment (DIMS) Spectacle Lenses Versus Orthokeratology Lenses (OKL) for Slowing Myopia Progression In Children Aged 6-12 Years. A Non-inferiority Randomized Clinical Trial. The NISDO Study.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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:
NISDO
Brief Summary:
The goal of this non-inferiority randomized clinical trial is to compare the myopia control efficacy of Ortho-K lenses (OKL) and Defocus (DIMS) spectacles in myopic children aged 6-12 years. The main question it aims to answer is:
\- Is the DIMS spectacle lens not worse than the OKL after 18 months of therapy?
The participants are randomly assigned to either OKL or DIMS spectacles and followed during 18 months of therapy.
\- Is the DIMS spectacle lens not worse than the OKL after 18 months of therapy?
The participants are randomly assigned to either OKL or DIMS spectacles and followed during 18 months of therapy.
Detailed Description:
None
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?: