Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OKL | Active Comparator |
| |
| DIMS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defocus Incorporated Multiple Segment (DIMS) Spectacles | Device | 18 months of therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Axial length growth of the eye | Length in mm is measured 18 months after therapy | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall eye length growth, defined as the sum of axial length and choroidal thickness | Length in mm is measured 18 months after therapy | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Choroidal thickness | Thickness is measured in um | During 18 months of therapy |
| Pupil size | Length in mm is measured 6 months after therapy | 6 months |
Inclusion criteria:
- Myopic children aged 6 to 12 years: Myopia of the 6 to 8-year-olds (inclusive): -1.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).
Myopia of the 9 to 12-year-olds (inclusive): -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lou-Ann Andersen | Vejle Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ophthalmic department, Vejle Hospital | Vejle | Southern Denmark | 7100 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 24, 2025 | Nov 24, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Orthokerathology lenses (OKL) | Device | 18 months of therapy. |
|
|
| Vision related quality of life using the questionnaire PREP2 | Range from "strongly disagree" to "strongly agree" | Prior to and 9 months after treatment initiation |