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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-11

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Exploratory Study on the Effectiveness of Myopia Control Lenses in Slowing Myopia Progression in Young Children

NCT06857864

Myopia

ACTIVE_NOT_RECRUITING NA

Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression

NCT05331378

Myopia, Progressive Myopia

ACTIVE_NOT_RECRUITING NA

Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression.

NCT05534022

Myopia

ACTIVE_NOT_RECRUITING NA

Myopia Progression Trial With Novel Myopia Control Design Spectacle Lenses

NCT04048148

Myopia

UNKNOWN NA

Comparison of Efficacy Between Two Myopia Control Lenses

NCT06148870

Myopia

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OD: MCL 1; OS: MCL 2

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.

Group Type EXPERIMENTAL

MCL 1

Intervention Type DEVICE

Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months.

MCL 2

Intervention Type DEVICE

Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months.

OD: MCL 2; OS: MCL 1

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.

Group Type EXPERIMENTAL

MCL 1

Intervention Type DEVICE

Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months.

MCL 2

Intervention Type DEVICE

Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MCL 1

Myopia Control Lens 1 (MCL 1) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months.

Intervention Type DEVICE

MCL 2

Myopia Control Lens 2 (MCL 2) is an ophthalmic lens intended to slow down eye growth in children. This lens will be dispensed to either the right or left eye and will be worn by the participant for a period of 6 months.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.)

Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No