Evaluation of the Effectiveness of a New Generation of Myopia Control Lens, Producing a Higher Myopic Control Signal Than That Produced by a Previous Generation Lens, on the Progression of Myopia in Children Aged 6 to 14 Years
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change from baseline in axial length
研究概览
简要总结
The goal of this clinical investigation is to learn how much a new generation of myopia control lens (MCL1 - Myopia Control Lens 1) is helpful in reducing myopia progression in children from 6 to 14 yo. The main questions it aims to answer is: How much this new generation of lens, called MCL1, slows down the growth of the eye? Researchers will compare MCL1 to a former generation of myopia control lens (i.e. MCL2) but with better vision quality.
Participants will:
- Wear MCL1 on right eye and MCL2 on left eye for 6 months and MCL2 on rigth eye and MCL1 on left eye for the next 6 months;
- Visit the hospital at 6 and 12 months for tests;
- Answer weekly questionnaires on compliance wearing glasses, quality of vision and out-of-school activities.
详细描述
Myopia is a global public health issue that could affect nearly 5 billion people by 2050. It progresses rapidly in children, increasing the risk of severe ocular diseases. Several solutions exist to slow its progression, including ophthalmic lenses, which are effective and free of side effects. Essilor® Stellest® lenses, incorporating H.A.L.T. technology with aspherical lenslets, slow axial eye elongation with an efficacy comparable to high-dose atropine.
A new version of this product provides an enhanced myopia-control signal thanks to increased optical parameters of the lenslets. A recent study has demonstrated its superior effectiveness in Asian children aged 6 to 10. The present study aims to assess its performance in European children, compared with another myopia control lens, which delivers the same myopia-control signal as the original Stellest® lens but with better visual quality.
The study will take into account interindividual variability in efficacy, particularly with respect to age-a key factor in myopia progression (which is high between ages 6 and 8). Three age groups will be analyzed (6-8, 9-11, and 12-14 years). A secondary objective is to explore the impact of individual ocular parameters on lens effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractive error in spherical equivalent (SE) ≤ -0.5 D and ≥ -4.5 D on each eye (autorefraction under cycloplegia)
- •Astigmatism ≤ 2.00 D for each eye
- •Anisometropia (difference in SE between the 2 eyes) ≤ 1.00 D
- •Corrected maximum distance visual acuity in each eye≥ 8/10 (equivalent to +0.1 LogMAR)
- •Written consent of the 2 holders of parental authority (or only one in the case of exclusive parental authority) and agreement of the participant
排除标准
- •Past or current use of any type of myopic control solution (braking lenses, atropine, orthokeratology, multifocal contact lenses, etc
- •Strabismus (in the test of masking near or far with the best correction)
- •Amblyopia
- •Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down syndrome, etc.)
- •Presence of trauma in at least one eye - Presence of inflammatory pathologies in at least one eye
- •History of intraocular surgery (cataracts, filtering surgery, intravitreal surgery) in at least one eye
- •Past or current use of growth hormones
- •Use of ocular or systemic drugs that, in the opinion of the investigator, may significantly affect pupil size, accommodation, or refractive status.
- •Wearing contact lenses
- •Allergy or intolerance to cycloplegic eye drops (cyclopentolate 0.5%)
- •Known allergy or intolerance to eyeglass frame materials
- •Children with specific visual disorders requiring personalized treatments other than conventional corrective lenses.
- •Intolerance to conventional optical corrections
- •Lack of cooperation in wearing corrective lenses
研究组 & 干预措施
OD: MCL 1; OS: MCL 2
Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 1, MCL 1 will be worn in the right eye, and MCL 2 in the left eye for a period of 6 months.
干预措施: MCL1 (Device)
OD: MCL 1; OS: MCL 2
Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 1, MCL 1 will be worn in the right eye, and MCL 2 in the left eye for a period of 6 months.
干预措施: MCL2 (Device)
OD: MCL 2; OS: MCL 1
Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 2, MCL 2 will be worn in the right eye, and MCL 1 in the left eye for a period of 6 months.
干预措施: MCL1 (Device)
OD: MCL 2; OS: MCL 1
Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL 1) and Myopia Control Lens 2 (MCL 2) design, with one type of lens in each eye throughout the study period. For Arm 2, MCL 2 will be worn in the right eye, and MCL 1 in the left eye for a period of 6 months.
干预措施: MCL2 (Device)
结局指标
主要结局
Change from baseline in axial length
时间窗: 6-month
次要结局
- Change from baseline in cycloplegic spherical equivalent(6-month)
- Effect of optical parameters, assessed at baseline, on myopia control efficacy of MCL1 and MCL2 at 6-month.(6-month)
- Effect of self-reported exposure time to natural light on myopia control efficacy of MCL1 and MCL2 at 6-month(6-month)