Targeted Lens Intervention for Myopic Anisometropia in Children

April 9, 2026 updated by: Essilor International

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:

    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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: More myopic eye: MCL1; Less myopic eye: MCL2
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.
Device: More myopic eye: MCL1; Less myopic eye: MCL2
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in axial length difference between the eyes
Time Frame: Base line, 12 months
Base line, 12 months
Change in cycloplegic spherical equivalent refraction between the eyes
Time Frame: Baseline, 12 months
Baseline, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in axial length difference between the eyes
Time Frame: Baseline, 6 months
Baseline, 6 months

Other Outcome Measures

Outcome Measure
Time Frame
Effect of baseline higher order aberrations on the change in axial length
Time Frame: Baseline, 6 months, 12 months
Baseline, 6 months, 12 months
Effect of wearing compliance on the change in axial length
Time Frame: Baseline, 6 months, 12 months
Baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Essilor International

Investigators

  • Principal Investigator: Theophila Ang, Essilor R&D Centre Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS10460

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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