Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SVL, SVL with passive red-light emission, MCL, MCL with passive red-light emission.
- Who it may be relevant to
- Registry conditions: Myopia. Basic parameters: 6 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Device SVL
Dispensed to one eye in Year 1 - Device SVL with passive red-light emission
Dispensed to the contralateral eye in Year 1. - Device MCL
Dispensed to one eye in Year 2 (if used SVL with passive red-light emission in Year 1). - Device MCL with passive red-light emission
Dispensed to the contralateral eye in Year 2 (if used SVL in Year 1).
Primary outcome measures
- Change in Axial Length [Time frame: From baseline to 12 months]
- Change in Axial Length [Time frame: From 12 months to 24 months]
Secondary outcome measures (2)
- Change in Spherical Equivalent Refraction [Time frame: From baseline to 12 months]
- Change in Spherical Equivalent Refraction [Time frame: From 12 months to 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Singapore · 1 center
- Essilor R&D Centre Singapore — Singapore
Publications
- 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. PMID 34863776
- 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. PMID 36049646
Identifiers
NCT: NCT06850168 · WS10367