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

Essilor International40 enrolled

Overview

This is a mono-centre, prospective, one-arm, unmask clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation compared to a single vision spectacle lens from the historical control group of another clinical trial NCT05331378. A total of 40 children will be recruited.

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 (Bao et al. 2022). A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy. This open clinical trial 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 (40 subjects) at the time of commencing treatment. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuities will also be compared between test lenses and control lenses of the historical control group to determine the quality of vision using test lenses

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myopia

Interventions

Test myopia control lenses (BSL)DEVICE

Myopia control spectacle lenses (test lenses) will be given to subjects throughout the 24 months trial.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 13 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 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. * 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 * History of myopia control intervention * Participation in any clinical study within 30 days of the Baseline visit.

Locations (1)

Essilor R&D Centre Singapore

Singapore, Singapore

Outcomes

Primary Outcomes

Axial Length

Change in ocular axial length (mm)

Time frame: 12 months and 24 months

Secondary Outcomes

Axial Length

Change in ocular axial length (mm)

Time frame: 6 months and 18 months

Spherical Equivalent Refraction

Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction.

Time frame: 6 months, 12 months, 18 months and 24 months

Data from ClinicalTrials.gov

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