Trials / Completed
CompletedNCT05134935
Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Children Aged 6-12 Years.
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
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Vejle Hospital · Academic / Other
- Sex
- All
- Age
- 6 Years – 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Defocus Incorporated Multiple Segment (DIMS) Spectacles | 18 months of therapy. |
| DEVICE | Orthokerathology lenses (OKL) | 18 months of therapy. |
Timeline
- Start date
- 2022-06-29
- Primary completion
- 2025-12-02
- Completion
- 2025-12-02
- First posted
- 2021-11-26
- Last updated
- 2026-01-07
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT05134935. Inclusion in this directory is not an endorsement.