Comparison of Efficacy Between Two Myopia Control Lenses

N/AActive Not RecruitingNCT06148870

Essilor International50 enrolled

Overview

This is a one-year, mono-centre, randomize, double-masked, monocular cross-over clinical trial designed to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopia progression.

The clinical trial aims to assess the safety and efficacy of a test lens, designed to modify the amount of myopic control signal on the retina without compromising vision. The primary goal of this clinical trial is to evaluate the effectiveness of the test lens in slowing down the increase of axial length and controlling myopia progression compared to the reference lens design.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Myopia

Interventions

Myopia Control Lens-1 (MCL1)DEVICE

The MCL1, is a myopia control lens that corrects refractive error and simultaneously creates myopia control signals. It will be worn on one eye for 6 months.

Myopia Control Lens-2 (MCL2)DEVICE

The MCL2, is a myopia control lens that corrects refractive error and simultaneously creates myopia control signals. It will be worn on the contralateral eye for 6 months.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form. * Equal to or greater than 6 years and not older than 11 years at time of informed consent and assent. * Spherical equivalent refractive error (SER) by manifest refraction between -0.50 and -4.75 D in each eye. * Astigmatism, if present, of not more than 2.00 D. * Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D. * Best corrected visual acuity in each eye better than +0.20 logMAR * Agree to wear study spectacles for at least 10 hours a day and 6 days a week * Willingness and ability to participate in trial for 1 year * Willingness and ability to attend scheduled visits * Not to involve concurrently in other myopia control treatments Exclusion Criteria: * History or presence of an Ocular disease, Strabismus, Amblyopia * Undergoing any myopia control intervention specifically Atropine and Orthokeratology * History of myopia control intervention specifically Atropine, Orthokeratology

Locations (1)

Essilor R&D Centre Singapore

Singapore, Singapore

Outcomes

Primary Outcomes

Change in Axial Length

To evaluate the effectiveness of the MCL2 in slowing myopia progression with respect to the change in Axial Length (AL) from baseline compared to MCL1 at 12-month.

Time frame: 12 months

Secondary Outcomes

Change in Spherical Equivalent Refraction

To evaluate the effectiveness of the MCL2 lens in slowing myopia progression with respect to the change in Spherical Equivalent Refraction (SER) from baseline compared to MCL1 at 12-month.

Time frame: 12 months

Data from ClinicalTrials.gov

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