Myopia
Conditions
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.
Interventions
DEVICEDefocus Incorporated Multiple Segment (DIMS) Spectacles
18 months of therapy.
DEVICEOrthokerathology lenses (OKL)
18 months of therapy.
Sponsors
Vejle Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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). * Anisometropia ≤ 1.50 D cycloplegic spherical equivalent refractive error. * Best corrected visual acuity at age 6 to 12 years (inclusive): 0.8 Snellen (equivalent to ≥ 3/5 letter on the 0.8 line = 78 ETDRS letters)
Exclusion criteria
* Manifest or intermittent squint. * Contraindications to the use of OKL comprising (not exhaustive): keratoconus, chronic allergic conjunctivitis and keratoconjunctivitis sicca. * Previous eye surgery. * Chronic eye disease demanding daily use of eye drops. * Non-compliance to eye examinations (unstable fixation or anxiety towards contact lenses). * Previous myopia control treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial length growth of the eye | 18 months | Length in mm is measured 18 months after therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Choroidal thickness | During 18 months of therapy | Thickness is measured in um |
| Pupil size | 6 months | Length in mm is measured 6 months after therapy |
| Vision related quality of life using the questionnaire PREP2 | Prior to and 9 months after treatment initiation | Range from strongly disagree to strongly agree |
Countries
Denmark
Outcome results
None listed