Myopic Progression
Conditions
Keywords
myopia control, orthokeratology
Brief summary
This is a two-year longitudinal study investigating the optical and structural effects of increased compression factor of orthokeratology lens on eyes and the corresponding effect on change in choroidal thickness and therefore myopic control.
Interventions
DEVICEOrthokeratology
Sponsors
Menicon Co., Ltd.
Queensland University of Technology
Aston University
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* 6 to 10 years old * Myopia: between 0.50 D and 4.00 D in both eyes * Astigmatism: \<1.50 D; ≤ 1.25 D for with-the-rule astigmatism (axes 180 ± 30); ≤ 0.50 D for astigmatism of other axes in both eyes * Anisometropia: ≤ 1.50 D * Symmetrical corneal topography with corneal toricity \<2.00 D in both eyes * Agree for randomization
Exclusion criteria
* Contraindications for orthokeratology wear (e.g. limbus-to-limbus corneal cylinder and dislocated corneal apex) * Any type of strabismus or amblyopia * Myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period * Rigid contact lenses (including orthokeratology lenses) experience * Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome) * Ocular conditions which might affect the refractive error (for example, cataract, ptosis) * Poor compliance for lens wear or follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial length | every 6 monthly in 2 years | axial progression of the eyeball |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer | every 6 monthly in 2 years | ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer |
| Corneal biomechanics (corneal response using ocular response) | every 6 monthly in 2 years | corneal response using ocular response |
| Accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer | every 6 monthly in 2 years | accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer using different accommodation targets |
| Choroidal thickness captured by Optical Coherent Tomographer (OCT) | every 6 monthly in 2 years | choroidal thickness captured by Optical Coherent Tomographer (OCT) and measured using a customized software |
Countries
China
Outcome results
None listed