MyopiaNCT06816446
Influence of Rodenstock Spectacle Lenses on Myopia Progression.
A study testing Single-vision lens in people with Myopia, run by Rodenstock GmbH at 1 site in Singapore.
Trial 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". Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Single-vision lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteSingapore
- Study dates
- 22 Jul 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
NUH
Singapore
Liyana Nur Farah Binte Makribi, 65162085 ext. +65, liyanaf@nus.edu.sg
About this study
Official title: Testing the Efficacy of Rodenstock Spectacle Lenses in Myopia Progression: a Two Year Clinical Trial
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.
Read more
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).
- Conditions
- Myopia
- Being tested
- Myopia control spectacle lens, Single-vision lens
- Keywords
- Myopia, Myopia control, Lenses, Light
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myopia control spectacle lensDevice
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.
Single-vision lensDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Myopia control spectacle lens Receives: Device: Myopia control spectacle lens |
| Control group | Active comparator | Single-vision spectacle lens Receives: Device: Single-vision lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical equivalent refraction
Change in spherical equivalent refraction
Measured: 2 years
Secondary outcomes (7)
Axial length
Change in axial length from baseline
Measured: 2 years
Peripheral refraction
Change in peripheral refraction from baseline
Measured: 2 years
Choroidal thickness
Change of choroidal thickness from baseline
Measured: 2 years
Visual acuity
Difference in central visual acuity between single vision lenses and myopia control lenses
Measured: 1 year
Contrast sensitivity
Difference in contrast sensitivity between single vision lenses and myopia control lenses
Measured: 1 year
Visual comfort
Difference in visual comfort between single vision lenses and myopia control lenses
Measured: 1 year
Light exposure
Impact of light exposure characteristics on myopia progression
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start22 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rodenstock GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Chen-Hsin Sun, Rodenstock GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816446
- Sponsor's protocol ID
- CTS01245
- Status last verified
- Sep 2025
- First submitted
- 4 Feb 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Team is undecided whether to share or not share the data. This may be amended.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of Rodenstock Spectacle Lenses in Myopia Progression: a Two Year Clinical Trial
- ClinicalTrials.gov ID
- NCT06816446
- Acronym / sponsor ID
- CTS01245
- Conditions
- Myopia
- Keywords
- Myopia, Myopia control, Lenses, Light
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Rodenstock GmbHIndustry (pharma, biotech, devices)
- Collaborators
- National University of Singapore, National University Hospital, Singapore
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Myopia control spectacle lensMyopia control spectacle lens |
| Control group | Active comparator | Device: Single-vision lensSingle-vision spectacle lens |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- All myopic children aged 6-12 years old
- Treatment naïve
- Sphere: -0.5 D till -5.00 D
- Anisometropia < 1.5D
- Astigmatism > -1.5D
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myopia control spectacle lensThe 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 | Intervention group |
| Single-vision lensThe 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. | Device | Control group |
Primary outcome
Spherical equivalent refraction
Time frame: 2 years
Change in spherical equivalent refraction
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No. Team is undecided whether to share or not share the data. This may be amended.
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-vision lens in people with Myopia, run by Rodenstock GmbH at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liyana Nur Farah Binte Makribi (65162085 ext. +65, liyananf@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spherical equivalent refraction (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.