Influence of Rodenstock Spectacle Lenses on Myopia Progression.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Myopia control spectacle lens, Single-vision lens.
- Who it may be relevant to
- Registry conditions: Myopia. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Testing the Efficacy of Rodenstock Spectacle Lenses in Myopia Progression: a Two Year Clinical Trial
Overview
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
- Device Myopia 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. - Device Single-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.
Primary outcome measures
- Spherical equivalent refraction [Time frame: 2 years]
Secondary outcome measures (7)
- Axial length [Time frame: 2 years]
- Peripheral refraction [Time frame: 2 years]
- Choroidal thickness [Time frame: 2 years]
- Visual acuity [Time frame: 1 year]
- Contrast sensitivity [Time frame: 1 year]
- Visual comfort [Time frame: 1 year]
- Light exposure [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Singapore · 1 center
- NUH — Singapore
Identifiers
NCT: NCT06816446 · CTS01245