Study Comparing Eye Growth Over Time in Children Using Two Myopia Control Lenses

Essilor

Status: Enrolling

Conditions: Myopia

Treatments: Device: MCL 2; Device: MCL 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07253064

WS10449

Details and patient eligibility

About

The goal of this clinical trial is to investigate the short-term changes in the eye structure while wearing two types of lenslet-based myopia control lenses over a period of 6 months in children aged 6 to 13 years with myopia. The main question it aims to answer is:

• How the eye responds, at each timepoint, to the two myopia control lenses by evaluating:

  1. Change in axial length

  2. Change in choroidal thickness

     Participants will:

• Wear the study spectacles

• Visit Essilor R&D Centre for follow-up sessions

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 13 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

OD: MCL 1; OS: MCL 2

Experimental group

Description:

Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 1, MCL 1 will be worn in the right eye, and MCL 2 in the left eye for a period of 6 months.

Treatment:

Device: MCL 1

Device: MCL 2

OD: MCL 2; OS: MCL 1

Experimental group

Description:

Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 2, MCL 2 will be worn in the right eye, and MCL 1 in the left eye for a period of 6 months.

Treatment:

Device: MCL 1

Device: MCL 2