Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression

Essilor

Status: Active, not recruiting

Conditions: Myopia; Myopia, Progressive

Treatments: Device: Test myopia control lenses; Device: Single vision lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT05331378

WS10258

Details and patient eligibility

About

This is a monocenter, randomized, controlled, parallel-group, double-masked clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation at baseline compared to a single vision spectacle lens (control). A total of 80 children will be recruited where 40 subjects will be allocated either to wear test lenses (group 1) or control lenses (group 2) for 1 year through randomization.

Full description

As myopia is a growing worldwide problem, it is important to better understand the range of possible treatments to slow the progression of myopia. Spectacle lenses with aspherical lenslets were shown to be effective in reducing myopia progression and axial length elongation in children in the previous clinical trial. A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy.

This double masked parallel group study will test the safety and effectiveness of a test lens designed to modify the area and amount of myopic defocus on the retina without compromising vision. The study population includes children in Singapore aged 8 to 13 years (80 subjects) at the time of commencing treatment. As age of myopia onset is known to be an important factor in rate of myopia progression, subject age at the time of enrollment will be used to balance randomization. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuity will also be compared between test lenses and control lenses to determine the quality of vision using test lenses.

Enrollment: 80 patients

Sex: All

Ages: 8 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 8 years and not older than 13 years at time of informed consent and assent.
• Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye.
• Astigmatism, if present, of not more than 1.50 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 equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
• Be in good general health based on his/her and parent's/guardian's knowledge. Absence of ocular disease with full ophthalmic examination. Without any ocular or systemic condition known to affect refractive status.
• History of myopia control intervention
• Absence of strabismus by cover test at near or distance wearing correction.
• Absence of amblyopia
• Without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.

Exclusion Criteria

• Vulnerability of subject
• Participation in any clinical study within 30 days of the Baseline visit.
• Sibling of existing participant of this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Test myopia control lenses

Experimental group

Description:

A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months.

Treatment:

Device: Test myopia control lenses

Single vision lenses

Other group

Description:

A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months.

Treatment:

Device: Single vision lenses