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

Not Applicable

Recruiting

• Conditions: Myopia

• Registration Number: NCT06850168
• Lead Sponsor: Essilor International

Brief Summary

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

Detailed Description

The clinical trial aims to assess the efficacy and safety of a test lens, designed to emit red-light when exposed to natural daylight that can produce a cumulative red-light exposure equivalent to the sham device (Dong et. al, 2023) when children spend about 30 minutes in a day. The primary goal of this clinical trial is to evaluate the effectiveness of the test lens in slowing down the increase of axial length and controlling myopia progression compared to the reference lens design.

Study Timeline

• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-27
• Study Start: 2025-06-26
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-07
• Primary Completion: 2027-10
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Axial Length	From 12 months to 24 months

Secondary Outcome Measures

Name	Time	Method
Change in Spherical Equivalent Refraction	From 12 months to 24 months

Trial Locations

Locations (1)

Essilor R&D Centre Singapore; 🇸🇬 Singapore, Singapore