AnisometropiaNCT07533149
Targeted Lens Intervention for Myopic Anisometropia in Children
A study testing More myopic eye: MCL1; Less myopic eye: MCL2 in people with Anisometropia and Myopia, run by Essilor International at 1 site in Singapore.
Trial summary
The goal of this clinical trial is to learn if our research spectacles will lower the difference in prescription (spectacles degree) between the eyes in children between 6 to 13 years old with anisometropic myopia. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Anisometropia, Myopia
- What is being tested?
- More myopic eye: MCL1; Less myopic eye: MCL2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Aug 2026to Nov 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Voluntary
- Informed consent of parent/guardian and assent of participant
- Age equal to or greater than 6 years old and less than 13 years at the time of signing informed consent and assent
- SER equal or less than -0.50 D and equal or greater than .5.00 D with astigmatism not more than 2.50 D
- Difference in SER (anisometropia) between two eyes .1.00 D
- Best corrected visual acuity (BCVA) better than or equal to +0.20 LogMAR in each eye
Show all 9Show fewer
- Agree to wear study spectacles for .12 hours/day and 7 days/week
- Willingness and ability to participate in investigation for 12 months and attend scheduled visits punctually
- Agree for no concurrent involvement in other myopia control treatment
Who cannot join
- History or presence of an ocular disease affecting refractive status
- History or presence of strabismus
- Presence of amblyopia
- Current or previous use of atropine and/or orthokeratology
- Known allergy to cycloplegic agents
- Contraindication to cycloplegic agents
- Cognitive or psychological vulnerability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Boudenne contact
Singapore1 site, 1 recruiting
- Recruiting
Essilor R&D Centre Singapore
Singapore
Celine Carimalo, +65 65899216, carimalc@essilor.com.sg
About this study
Official title: Clinical Investigation of Targeted Lens Intervention in the Management of Myopic Anisometropia in Children
The goal of this clinical trial is to learn if our research spectacles will lower the difference in prescription (spectacles degree) between the eyes in children between 6 to 13 years old with anisometropic myopia. Anisometropic myopia is when the difference in myopia prescription between the two eyes are more than 1 diopter. The main question it aims to answer is:
- How the eye responds to the research spectacles over time by measuring:
Read more
- Change in axial length: the physical length of the eye from front to back.
- Change in cycloplegic spherical equivalent refraction: an accurate measurement of the eye's prescription taken while the focusing muscles are temporarily relaxed with eye drops. Participants will:
- Wear the study spectacles
- Visit Essilor R\&D Centre and an eye clinic for follow-up sessions
- Conditions
- Anisometropia, Myopia
- Being tested
- More myopic eye: MCL1; Less myopic eye: MCL2
- Keywords
- myopia control, anisometropia, axial length, spherical equivalent refraction
- Medical subject headings
- Anisometropia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
More myopic eye: MCL1; Less myopic eye: MCL2Device
Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL1) and Myopia Control Lens 2 (MCL2) design, with one type of lens in each eye throughout the study period. MCL1 will be worn in the more myopic eye, and MCL2 in the less myopic eye for a period of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| More myopic eye: MCL1; Less myopic eye: MCL2 | Experimental | Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL1) and Myopia Control Lens 2 (MCL2) design, with one type of lens in each eye throughout the study period. MCL1 will be worn in the more myopic eye, and MCL2 in the less myopic eye for a period of 12 months. Receives: Device: More myopic eye: MCL1; Less myopic eye: MCL2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in axial length difference between the eyes
Measured: Base line, 12 months
Change in cycloplegic spherical equivalent refraction between the eyes
Measured: Baseline, 12 months
Secondary outcomes (1)
Change in axial length difference between the eyes
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start13 Aug 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnisometropiaStudies of the same condition, open and under way.
- More trials run by Essilor InternationalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theophila Ang, Principal investigator, Essilor R&D Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533149
- Sponsor's protocol ID
- WS10460
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Huang Y, Liu C, Chang X, Cui Z, Yang Q, Drobe B, Bullimore MA, Chen H, Bao J. Myopia control efficacy of spectacle lenses with highly aspherical lenslets: results of a 5-year follow-up study. Eye Vis (Lond). 2025 Mar 5;12(1):10. doi: 10.1186/s40662-025-00427-3.
PubMed 40038807Lu J, Long W, Zheng B, Liang Z, Hou F, Cui D. Effects of weekly unilateral application of 1% atropine on reducing anisometropia in Chinese children with low myopia. J Optom. 2025 Oct-Dec;18(4):100578. doi: 10.1016/j.optom.2025.100578. Epub 2025 Aug 26.
PubMed 40865156
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Targeted Lens Intervention in the Management of Myopic Anisometropia in Children
- ClinicalTrials.gov ID
- NCT07533149
- Acronym / sponsor ID
- WS10460
- Conditions
- Anisometropia, Myopia
- Keywords
- myopia control, anisometropia, axial length, spherical equivalent refraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 16 Apr 2026 (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 goal of this clinical trial is to learn if our research spectacles will lower the difference in prescription (spectacles degree) between the eyes in children between 6 to 13 years old with anisometropic myopia. Anisometropic myopia is when the difference in myopia prescription between the two eyes are more than 1 diopter. The main question it aims to answer is:
- How the eye responds to the research spectacles over time by measuring:
- Change in axial length: the physical length of the eye from front to back.
- Change in cycloplegic spherical equivalent refraction: an accurate measurement of the eye's prescription taken while the focusing muscles are temporarily relaxed with eye drops. Participants will:
- Wear the study spectacles
- Visit Essilor R\&D Centre and an eye clinic for follow-up sessions
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| More myopic eye: MCL1; Less myopic eye: MCL2 | Experimental | Device: More myopic eye: MCL1; Less myopic eye: MCL2Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL1) and Myopia Control Lens 2 (MCL2) design, with one type of lens in each eye throughout the study period. MCL1 will be worn in the more myopic eye, and MCL2 in the less myopic eye for a period of 12 months. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Voluntary
- Informed consent of parent/guardian and assent of participant
- Age equal to or greater than 6 years old and less than 13 years at the time of signing informed consent and assent
- SER equal or less than -0.50 D and equal or greater than .5.00 D with astigmatism not more than 2.50 D
- Difference in SER (anisometropia) between two eyes .1.00 D
Key exclusion criteria (7 listed)
- History or presence of an ocular disease affecting refractive status
- History or presence of strabismus
- Presence of amblyopia
- Current or previous use of atropine and/or orthokeratology
- Known allergy to cycloplegic agents
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 |
|---|---|---|
| More myopic eye: MCL1; Less myopic eye: MCL2Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL1) and Myopia Control Lens 2 (MCL2) design, with one type of lens in each eye throughout the study period. MCL1 will be worn in the more myopic eye, and MCL2 in the less myopic eye for a period of 12 months. | Device | More myopic eye: MCL1; Less myopic eye: MCL2 |
Primary outcome
Change in axial length difference between the eyes
Time frame: Base line, 12 months
Change in cycloplegic spherical equivalent refraction between the eyes
Time frame: Baseline, 12 months
1 secondary outcome
Change in axial length difference between the eyes
Time frame: Baseline, 6 months
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 15 Sep 2026.
- Background: PubMed 40038807Li X, Huang Y, Liu C, Chang X, Cui Z, Yang Q, Drobe B, Bullimore MA, Chen H, Bao J. Myopia control efficacy of spectacle lenses with highly aspherical lenslets: results of a 5-year follow-up study. Eye Vis (Lond). 2025 Mar 5;12(1):10. doi: 10.1186/s40662-025-00427-3.
- Background: PubMed 40865156Lu J, Long W, Zheng B, Liang Z, Hou F, Cui D. Effects of weekly unilateral application of 1% atropine on reducing anisometropia in Chinese children with low myopia. J Optom. 2025 Oct-Dec;18(4):100578. doi: 10.1016/j.optom.2025.100578. Epub 2025 Aug 26.
- Individual participant dataSharing planned: No
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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.
Thomas Boudenne contact
Theophila Ang principal investigator
Essilor R&D Centre Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing More myopic eye: MCL1; Less myopic eye: MCL2 in people with Anisometropia and Myopia, run by Essilor International 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 9 inclusion and 7 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 15 Sep 2026. 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 Celine Carimalo (+65 6589 9216, carimalc@essilor.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in axial length difference between the eyes (time frame: Base line, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07533149, which also lists 2 linked publications.
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 15 Sep 2026.