Rodenstock Spectacle Lenses for Myopia in Children
Influence of Rodenstock Spectacle Lenses on Myopia Progression.
Recruiting
N/AInterventional Study
Myopia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 – 12
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
185 (estimated)
Sponsor
Rodenstock GmbH · Industry
Who this trial is looking for
This trial is looking for children aged 6-12 who are nearsighted. Participants will use special glasses to see if they help slow down myopia over two years.
Are You a Good Fit for This Trial?
You may be able to join if
I am aged 6 to 12 years old.
I have been diagnosed with myopia.
My eyesight is between -0.5 D and -5.00 D.
I do not have more than 1.5 D difference in eyesight between my two eyes.
My astigmatism is worse than -1.5 D.
I can see well enough with correction.
I have never received treatment for my myopia.
You may not be able to join if
I am currently using treatments for my myopia.
I have other eye conditions besides myopia or astigmatism.
I have ocularmotor conditions like nystagmus or strabismus.
I have chronic physical or mental disabilities.
I have issues that would prevent safe eye dilation.
My corneal astigmatism is worse than 1.5 D.
I have irregular astigmatism.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 individual…
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).
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 cu…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.