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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | (Year 1) OD: SVL with passive red-light emission; OS: SVL (Year 2) OD: MCL; OS: MCL with passive red-light emission |
|
| Group B | Experimental | (Year 1) OD: SVL; OS: SVL with passive red-light emission (Year 2) OD: MCL with passive red-light emission; OS: MCL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SVL | Device | Dispensed to one eye in Year 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Axial Length | From baseline to 12 months | |
| Change in Axial Length | From 12 months to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spherical Equivalent Refraction | From baseline to 12 months | |
| Change in Spherical Equivalent Refraction | From 12 months to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celine Carimalo | Contact | +65 67134617 | carimalc@essilor.com.sg | |
| Thomas Boudenne | Contact | thomas.boudenne@essilor.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Tan | Essilor R&D Centre Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essilor R&D Centre Singapore | Recruiting | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34863776 | Background | Jiang Y, Zhu Z, Tan X, Kong X, Zhong H, Zhang J, Xiong R, Yuan Y, Zeng J, Morgan IG, He M. Effect of Repeated Low-Level Red-Light Therapy for Myopia Control in Children: A Multicenter Randomized Controlled Trial. Ophthalmology. 2022 May;129(5):509-519. doi: 10.1016/j.ophtha.2021.11.023. Epub 2021 Dec 1. | |
| 36049646 | Background |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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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.
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| SVL with passive red-light emission |
| Device |
Dispensed to the contralateral eye in Year 1. |
|
| MCL | 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 | Device | Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1). |
|
| Dong J, Zhu Z, Xu H, He M. Myopia Control Effect of Repeated Low-Level Red-Light Therapy in Chinese Children: A Randomized, Double-Blind, Controlled Clinical Trial. Ophthalmology. 2023 Feb;130(2):198-204. doi: 10.1016/j.ophtha.2022.08.024. Epub 2022 Aug 29. |