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NCT Number: NCT07533149

Targeted Lens Intervention for 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:

1. Change in axial length: the physical length of the eye from front to back. 2. 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

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Key information

Conditions

Anisometropia Eye Diseases Myopia Refractive Errors

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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

Treatment and study plan

More myopic eye: MCL1; Less myopic eye: MCL2

Device

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.

Primary outcomes

  1. Change in axial length difference between the eyes

    Time frame: Base line, 12 months

  2. Change in cycloplegic spherical equivalent refraction between the eyes

    Time frame: Baseline, 12 months

Secondary outcomes

  1. Change in axial length difference between the eyes

    Time frame: Baseline, 6 months

Other outcomes

  1. Effect of baseline higher order aberrations on the change in axial length

    Time frame: Baseline, 6 months, 12 months

  2. Effect of wearing compliance on the change in axial length

    Time frame: Baseline, 6 months, 12 months

Study contacts

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

Celine Carimalo

CONTACT

[email protected]

+65 6589 9216

Thomas Boudenne

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Essilor International

Industry

Registry information

Official study title

Clinical Investigation of Targeted Lens Intervention in the Management of Myopic Anisometropia in Children

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2026
Registry last updated
Apr 16, 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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