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NCT Number: NCT07810725

Effect of a Myopia Control Lens on the Astigmatism in Children

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

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Key information

Conditions

Astigmatism Eye Diseases Myopia Refractive Errors

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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.)

Exclusion criteria

  • History or presence of:
  • An ocular disease
  • Strabismus
  • Amblyopia

Treatment and study plan

Lenslet-based myopia control spectacle lens

Device

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.

Primary outcomes

  1. Change from baseline in the Cylinder value through non cycloplegic autorefraction

    Time frame: 12 months

Secondary outcomes

  1. Change from baseline in the Keratometry value measured using a Keratometer

    Time frame: 12 months

  2. Change from baseline in the Axial Length value measured using a biometer

    Time frame: 12 months

  3. Quality of Life while wearing the study lenses measured through Questionnaire

    Time frame: Baseline, 6 and 12 months

Other outcomes

  1. Safety: Change from baseline in the Axial Length value measured using a biometer

    Time frame: 3 and 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Celine Carimalo

CONTACT

[email protected]

+65 67134600

Thomas Boudenne

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Essilor International

Industry

Registry information

Official study title

A Monocentre, Single-Arm Trial to Study the Effect of Lens Inspired by Myopia Control Solutions on the Astigmatism of a Child

Acronym: MAC

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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