Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression

Overview

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 Title of Study: “A Double-masked, Randomized, 2-armed Comparative Study of a Myopia Control Lens (Test Lens) Versus Single Vision Lens (Control Lens).”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2024

Detailed 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.

Interventions

  • Device: Test myopia control lenses
    • A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months.
  • Device: Single vision lenses
    • A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months.

Arms, Groups and Cohorts

  • Experimental: Test myopia control lenses
    • A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months.
  • Other: Single vision lenses
    • A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months.

Clinical Trial Outcome Measures

Primary Measures

  • Axial Length
    • Time Frame: 12 months
    • Change in ocular axial length (mm) measured using Lenstar Optical Biometer.

Secondary Measures

  • Spherical Equivalent Refraction
    • Time Frame: 6 months and 12 months
    • Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction.
  • Axial Length
    • Time Frame: 6 months
    • Change in ocular axial length (mm) measured using Lenstar Optical Biometer.
  • Carry-over Effect
    • Time Frame: 18 months and 24 months
    • Change in ocular axial length (mm) measured using Lenstar Optical Biometer after switching to STELLEST™ lenses

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 13 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Essilor International
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andrew Tan, Principal Investigator, Essilor R&D Centre Singapore

References

Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.

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