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

ConditionMyopia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-11

SponsorEssilor International

About this trial

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

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

SVL
SVL with passive red-light emission
MCL
MCL with passive red-light emission

Treatment groups

35 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Essilor International

Lead sponsor

Source ClinicalTrials.gov