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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-26

Study Completion Date

2027-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a 2-year, randomized, double-masked, contralateral, exploratory clinical trial with the objective to evaluate the efficacy of two test lenses designed with passive red-light emission in the control of myopia progression. The subject starts by wearing standard SVL, designed with passive red-light emission in one eye, and standard SVL in the contralateral eye. After 1 year, the eye wearing SVL designed with passive red-light emission will be replaced with standard MCL, and the contralateral eye will be replaced with standard MCL designed with passive red-light emission. At the end of the 2-year period, each eye would be exposed to lenses designed with passive red-light emission for 1 year each. There will be a total of 11 study visits with follow-up periods at 6 months, 12 months, 18 months and 24 months.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

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

Group Type EXPERIMENTAL

SVL

Intervention Type DEVICE

Dispensed to one eye in Year 1

SVL with passive red-light emission

Intervention Type DEVICE

Dispensed to the contralateral eye in Year 1.

MCL

Intervention Type DEVICE

Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1).

MCL with passive red-light emission

Intervention Type DEVICE

Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).

Group B

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

Group Type EXPERIMENTAL

SVL

Intervention Type DEVICE

Dispensed to one eye in Year 1

SVL with passive red-light emission

Intervention Type DEVICE

Dispensed to the contralateral eye in Year 1.

MCL

Intervention Type DEVICE

Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1).

MCL with passive red-light emission

Intervention Type DEVICE

Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).

Interventions

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SVL

Dispensed to one eye in Year 1

Intervention Type DEVICE

SVL with passive red-light emission

Dispensed to the contralateral eye in Year 1.

Intervention Type DEVICE

MCL

Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1).

Intervention Type DEVICE

MCL with passive red-light emission

Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No