NCT07533149

Brief Summary

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:

  • Wear the study spectacles
  • Visit Essilor R\&D Centre and an eye clinic for follow-up sessions

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Jul 2027

Study Start

First participant enrolled

April 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

AnisometropiaMyopia

Keywords

myopia controlanisometropiaaxial lengthspherical equivalent refraction

Outcome Measures

Primary Outcomes (2)

  • Change in axial length difference between the eyes

    Base line, 12 months

  • Change in cycloplegic spherical equivalent refraction between the eyes

    Baseline, 12 months

Secondary Outcomes (1)

  • Change in axial length difference between the eyes

    Baseline, 6 months

Other Outcomes (2)

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

    Baseline, 6 months, 12 months

  • Effect of wearing compliance on the change in axial length

    Baseline, 6 months, 12 months

Study Arms (1)

More myopic eye: MCL1; Less myopic eye: MCL2

EXPERIMENTAL

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

Interventions

More myopic eye: MCL1; Less myopic eye: MCL2DEVICE

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.

More myopic eye: MCL1; Less myopic eye: MCL2

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Essilor R&D Centre Singapore

Singapore, Singapore

Location

Related Publications (2)

  • Li X,Huang Y,Liu C,Chang X,Cui Z,Yang Q,Drobe B,Bullimore MA,Chen H,Bao J

    BACKGROUND

  • Lu J, Long W, Zheng B, Liang Z, Hou F, Cui D. Effects of weekly unilateral application of 1% atropine on reducing anisometropia in Chinese children with low myopia. J Optom. 2025 Oct-Dec;18(4):100578. doi: 10.1016/j.optom.2025.100578. Epub 2025 Aug 26.

    PMID: 40865156BACKGROUND

MeSH Terms

Conditions

AnisometropiaMyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Theophila Ang

    Essilor R&D Centre Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Celine Carimalo

CONTACT

+65 6589 9216carimalc@essilor.com.sg

Thomas Boudenne

CONTACT

thomas.boudenne@essilor.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)