How two lenslet-based glasses affect eye growth in children with myopia

A Monocentre, Randomized, Contralateral Trial to Study the Effect of Temporal Changes in Ocular Biometry of Two Myopia Control Lenses

This study will test two different lenslet-based spectacle lenses to see if they change eye growth (axial length) and choroidal thickness over six months in children ages 6–13 with myopia.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 6 Years to 13 Years
• Sex: All
• Sponsor: Essilor International (industry)
• Locations: 1 site (Singapore)
• Trial ID: NCT07253064 on ClinicalTrials.gov

What this trial studies

Children with myopia aged 6–13 will be fitted with one of two lenslet-based myopia control spectacles and followed for six months at the Essilor R&D Centre in Singapore. At scheduled visits, technicians will measure axial length and choroidal thickness to track short-term structural changes in the eye. Participants will wear the assigned study spectacles daily and return for follow-up sessions where measurements will be taken at defined timepoints. The trial directly compares the two lens designs' effects on eye growth over time.

Who should consider this trial

Good fit: Children aged 6–13 with myopia between −0.50 D and −4.75 D, astigmatism ≤2.00 D, anisometropia ≤1.00 D, best-corrected visual acuity better than 0.2 logMAR in each eye, no prior myopia control treatments or ocular disease, and willing to wear study spectacles and attend scheduled visits for six months.

Not a fit: Children with refractive error outside the specified range, prior myopia control interventions, ocular disease, strabismus or amblyopia, or those unable to commit to wearing the spectacles and attending follow-ups are unlikely to gain benefit from this study.

Why it matters

Potential benefit: If successful, these lenses could slow axial elongation in children and reduce the long-term risk of high myopia and its complications.

How similar studies have performed: Previous trials of lenslet-based spectacle designs (for example DIMS-style lenses) have demonstrated slowed axial elongation and reduced myopia progression over one to two years, so the general approach has supporting evidence though this specific short-term comparison is newer.

Eligibility criteria

Inclusion Criteria:

* Volunteer participant
* Informed consent of parent or guardian and assent of participant
* Age: Equal to or greater than 6 years but not older than 13 years at the time of informed consent and assent.
* Refractive error (manifest refraction):

  * Equal or less than -0.50 D or equal or greater than -4.75D.
  * Astigmatism should be less than or equal to 2.00D.
* 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 6 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.)

Exclusion Criteria:

* History or presence of:

  * An ocular disease
  * Strabismus
  * Amblyopia
* Currently or previously on any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)

Where this trial is running

Singapore

• Essilor R&D Centre Singapore — Singapore, Singapore (RECRUITING)

Study contacts

• Principal investigator: Aparna Gopalakrishnan — Essilor R&D Centre Singapore
• Study coordinator: Celine Carimalo

Conditions: Myopia, myopia control, axial length, choroidal thickness