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

Essilor

Status: Not yet enrolling

Conditions: Myopia

Treatments: Device: SVL; Device: MCL; Device: MCL with passive red-light emission; Device: SVL with passive red-light emission

Study type: Interventional

Funder types: Industry

Identifiers

NCT06850168

WS10367

Details and patient eligibility

About

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

Enrollment: 35 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

Group A

Experimental group

Description:

(Year 1) OD: SVL with passive red-light emission; OS: SVL (Year 2) OD: MCL; OS: MCL with passive red-light emission

Treatment:

Device: SVL with passive red-light emission

Device: MCL with passive red-light emission

Device: MCL

Device: SVL

Group B

Experimental group

Description:

(Year 1) OD: SVL; OS: SVL with passive red-light emission (Year 2) OD: MCL with passive red-light emission; OS: MCL

Treatment:

Device: SVL with passive red-light emission

Device: MCL with passive red-light emission

Device: MCL

Device: SVL