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Targeted Lens Intervention for Myopic Anisometropia in Children

Sponsor: Essilor International • ClinicalTrials.gov ID: NCT07533149

Registry updated: 2026-09-15

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Description

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

Interventions

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.

Eligibility criteria

Inclusion Criteria: 1. Voluntary 2. Informed consent of parent/guardian and assent of participant 3. Age equal to or greater than 6 years old and less than 13 years at the time of signing informed consent and assent 4. SER equal or less than -0.50 D and equal or greater than .5.00 D with astigmatism not more than 2.50 D 5. Difference in SER (anisometropia) between two eyes .1.00 D 6. Best corrected visual acuity (BCVA) better than or equal to +0.20 LogMAR in each eye 7. Agree to wear study spectacles for .12 hours/day and 7 days/week 8. Willingness and ability to participate in investigation for 12 months and attend scheduled visits punctually 9. Agree for no concurrent involvement in other myopia control treatment Exclusion Criteria: 1. History or presence of an ocular disease affecting refractive status 2. History or presence of strabismus 3. Presence of amblyopia 4. Current or previous use of atropine and/or orthokeratology 5. Known allergy to cycloplegic agents 6. Contraindication to cycloplegic agents 7. Cognitive or psychological vulnerability

Conditions

Anisometropia Myopia

Locations

Essilor R&D Centre Singapore — Singapore, Singapore

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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