NCT07810725

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
17mo left

Started Sep 2026

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 Progress6%
Sep 2026Mar 2028

Study Start

First participant enrolled

September 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

September 15, 2026

Status Verified

August 1, 2026

Enrollment Period

1.4 years

First QC Date

September 2, 2026

Last Update Submit

September 10, 2026

Conditions

AstigmatismMyopia

Keywords

Myopia controlAstigmatismaxial lengthcylinder

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the Cylinder value through non cycloplegic autorefraction

    12 months

Secondary Outcomes (3)

  • Change from baseline in the Keratometry value measured using a Keratometer

    12 months

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

    12 months

  • Quality of Life while wearing the study lenses measured through Questionnaire

    Baseline, 6 and 12 months

Other Outcomes (1)

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

    3 and 6 months

Study Arms (1)

Myopia Control Lens Prototype

EXPERIMENTAL

Each participant will be fitted with a prototype lenslet-based spectacle lens to be worn continuously throughout the 12-month study period. Following the baseline and dispensing visit, participants will undergo follow-up assessments at 3, 6, and 12 months. These intervals will monitor change of myopia and astigmatism through standard refraction and ocular biometry measurements. Device Details: The myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). The lenses will be dispensed and worn daily for the duration of the 12-month evaluation period.

Device: Lenslet-based myopia control spectacle lens

Interventions

Lenslet-based myopia control spectacle lensDEVICE

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.

Myopia Control Lens Prototype

Eligibility Criteria

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

You may qualify if:

  • 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.)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AstigmatismMyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Si Ying Lim

    EssilorLuxottica

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Celine Carimalo

CONTACT

+65 67134600carimalc@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

September 2, 2026

First Posted

September 9, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

September 15, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share