AstigmatismMACNCT07810725
Effect of a Myopia Control Lens on the Astigmatism in Children
A study of Astigmatism and Myopia, run by Essilor International.
Trial summary
The goal of this clinical trial is to investigate over a one-year period the effect of myopia control spectacle lenses on astigmatism in children aged 6 to 13 years with myopia and astigmatism. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Astigmatism, Myopia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to 1 Mar 2028
- Phase
- Interventional
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
- Volunteer participant
- Informed consent of parent or guardian and assent of participant
- Age equal to or greater than 6 years and less than 13 years (before 13th birthday) at the time of consent.
- Refractive error (manifest refraction):
- With the rule astigmatism (defined as vertical meridian has steeper curvature, Astigmatism prescribing axis in between: 0 to 34° and 146 to 180°)
- Astigmatism should be more than or equal to 1.50D
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- Least myopic meridian equal or less than -0.50D
- Most myopic meridian equal or greater than -5.50D.
- Anisometropia should be less than or equal to 1.00D
- Best corrected visual acuity: Better than 0.2 logMAR in each eye
- Willingness and ability to:
- participate in trial for at least 12 months.
- attend scheduled visits.
- not to be involved in other myopia control treatments concurrently.
- No history of any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)
Who cannot join
- History or presence of:
- An ocular disease
- Strabismus
- Amblyopia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Thomas Boudenne contact
About this study
Official title: A Monocentre, Single-Arm Trial to Study the Effect of Lens Inspired by Myopia Control Solutions on the Astigmatism of a Child
The goal of this clinical trial is to investigate over a one-year period the effect of myopia control spectacle lenses on astigmatism in children aged 6 to 13 years with myopia and astigmatism.
The main question it aims to answer is:
- How does the eye respond at each timepoint to the myopia control lenses?
By evaluating: the change in astigmatism (cylinder) after one year?
Participants will:
Wear the assigned study spectacles daily
Visit the Essilor R\&D Centre for scheduled follow-up sessions
- Conditions
- Astigmatism, Myopia
- Being tested
- Lenslet-based myopia control spectacle lens
- Keywords
- Myopia control, Astigmatism, axial length, cylinder
- Medical subject headings
- Astigmatism, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenslet-based myopia control spectacle lensDevice
Device Details:
The myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). In this specific device, the lenslet are located in concentric rings.
| Study group | Role | What they receive |
|---|---|---|
| Myopia Control Lens Prototype | Experimental | Each participant will be fitted with a prototype lenslet-based spectacle lens to be worn continuously throughout the 12-month study period. Following the baseline and dispensing visit, participants will undergo follow-up assessments at 3, 6, and 12 months. These intervals will monitor change of myopia and astigmatism through standard refraction and ocular biometry measurements.
Device Details:
The myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). The lenses will be dispensed and worn daily for the duration of the 12-month evaluation period. Receives: Device: Lenslet-based myopia control spectacle lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Cylinder value through non cycloplegic autorefraction
Measured: 12 months
Secondary outcomes (3)
Change from baseline in the Keratometry value measured using a Keratometer
Measured: 12 months
Change from baseline in the Axial Length value measured using a biometer
Measured: 12 months
Quality of Life while wearing the study lenses measured through Questionnaire
PREP 2 questionnaire: Pediatric Refractive Error Profile 2 The questionnaire is designed to assess the vision-specific quality of life in children who wear glasses or contact lenses. It covers seven areas: Vision, Symptoms, Handling, Peer Perception, Activities, Appearance, and Overall.
The Child form is a 5 point agreement scale ranging from: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree
The parent form is a 10 point agreement scale ranging from 1=likes and 10=dislikes
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startSep 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Si Ying Lim, Principal investigator, EssilorLuxottica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810725
- Sponsor's protocol ID
- WS10487
- Acronym
- MAC
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 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