Myopia
Conditions
Keywords
Myopia, Myopia control, Lenses, Light
Brief summary
The prevalence of myopia in Singapore is among the highest in the world, with 65 percent of our children being myopic by Primary 6, and 83 percent of young adults being myopic. As such, Singapore is often labelled as the Myopia Capital of the World. By 2050, it is projected that 80 to 90 per cent of all Singaporean adults above 18 years old will be myopic and 15 to 25 percent of these individuals may have high myopia. High myopia (spherical equivalent refraction ≤ -5 D) puts one at risk of many eye disorders later in life, such as early cataracts, glaucoma and macular degeneration. These complications often cause significant morbidity and may even be sight-threatening. Hence there is an urgent and growing need for synergistic efforts to counter myopia. The goal of this clinical trial is to test the efficacy of spectacle lenses in controlling the progression of myopia in children (aged 6-12 years) over a period of 2 years. In addition, this trial aims to evaluate the impact of these spectacle lenses on central visual performance and visual comfort. Therefore, in this randomised, double-masked clinical trial, one hundred and eighty-five (n=185) subjects aged 6-12 years with mild or moderate myopia (\< -5D) will be randomised in a 1:1 allocation ratio into three strata defined by age 6-8, 8-10 and 10-12 years to ensure age balance between the two arms (control group - single vision lenses and intervention group - myopia control lenses, gender matched). In the control group, after one year (12 months) of wearing single vision lenses, the children will switch to the myopia control lenses (crossover design).
Interventions
DEVICEMyopia control spectacle lens
The intervention group will wear specially designed lenses that aim to slow the progression of myopia. Follow-up visits will take place at regular intervals.
DEVICESingle-vision lens
The control group will wear single vision lenses for one year. They will then switch to the myopia control lens for a further year. Follow-up visits will take place at regular intervals.
Sponsors
National University of Singapore
National University Hospital, Singapore
Rodenstock GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* All myopic children aged 6-12 years old * Treatment naïve * Sphere: -0.5 D till -5.00 D * Anisometropia \< 1.5D * Astigmatism \> -1.5D * Monocular best corrected visual acuity +0.1 logMAR or better, and binocular visual acuity 0.0 logMAR or better
Exclusion criteria
* On current myopia control treatments * Any diagnosed ocular conditions besides myopia or astigmatism. * No diagnosed ocularmotor conditions (Nystagmus, strabismus, etc.) * Any diagnosed chronic physical or mental disabilities * Contraindication in cycloplegia (high IOP, etc.) * Corneal astigmatism \> 1.5 D; irregular astigmatism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spherical equivalent refraction | 2 years | Change in spherical equivalent refraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral refraction | 2 years | Change in peripheral refraction from baseline |
| Choroidal thickness | 2 years | Change of choroidal thickness from baseline |
| Visual acuity | 1 year | Difference in central visual acuity between single vision lenses and myopia control lenses |
| Axial length | 2 years | Change in axial length from baseline |
| Visual comfort | 1 year | Difference in visual comfort between single vision lenses and myopia control lenses |
| Light exposure | 2 years | Impact of light exposure characteristics on myopia progression |
| Contrast sensitivity | 1 year | Difference in contrast sensitivity between single vision lenses and myopia control lenses |
Countries
Singapore
Contacts
Primary ContactLiyana Nur Farah Binte Makribi
Outcome results
None listed