Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression

Essilor International35 enrolled

Overview

The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is: Does the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children? Researchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression. Participants will: * Wear the study spectacles * Visit Essilor R\&D Centre for follow-up sessions

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Myopia

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent. * Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D. * Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D. * Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen). * Be in good general health, based on his/her and parent's/guardian's knowledge. * Agree to wear spectacles for \>12 hours/day and at least 6 days/week. * Willingness and ability to participate in investigation for 2 years and attend scheduled visits. Exclusion Criteria: * Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.) * Any binocular vision anomalies * Amblyopia * Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month. * Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state. * Participation in any clinical investigation within 30 days of the baseline visit.

Outcomes

Primary Outcomes

Change in Axial Length

Time frame: From baseline to 12 months