Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Children Aged 6-12 Years.
Not Applicable
Active, not recruiting
- Conditions
- Myopia
- Registration Number
- NCT05134935
- Lead Sponsor
- Vejle Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Axial length growth of the eye 18 months Length in mm is measured 18 months after therapy
- Secondary Outcome Measures
Name Time Method Overall eye length growth, defined as the sum of axial length and choroidal thickness 18 months Length in mm is measured 18 months after therapy
Trial Locations
- Locations (1)
The Ophthalmic department, Vejle Hospital
🇩🇰Vejle, Southern Denmark, Denmark
The Ophthalmic department, Vejle Hospital🇩🇰Vejle, Southern Denmark, Denmark