Efficacité de Verres de Freination Myopique Dans Une Population de Jeunes Adultes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Axial length
研究概览
简要总结
The goal of this clinical trial is to learn if myopia-control eyeglass lenses (Essilor® Stellest® 2.0) can slow down the progression of short-sightedness (myopia) in young adults, compared with standard single-vision lenses. The main questions it aims to answer are:
Does wearing Stellest® 2.0 lenses slow the increase in eye length (axial length) after 1 year, compared with standard lenses? Does wearing Stellest® 2.0 lenses reduce the change in glasses prescription and the occurrence of eye complications after 2 years, compared with standard lenses? How well do participants tolerate the Stellest® 2.0 lenses in the first weeks of wear? Researchers will compare Stellest® 2.0 myopia-control lenses to standard single-vision lenses to see if they reduce the worsening of myopia.
Participants will:
Wear either the study glasses or standard glasses every day, at least 12 hours a day, for 2 years Attend an eye exam and vision check at the start of the study, after 1 year, and after 2 years Complete three phone check-ins during the first 3 months to report on comfort and how well they tolerate their glasses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spherical equivalent (SE) measured under cycloplegia using an autorefractometer, within the range 4 D ≤ SE ≤ -0.75 D for each eye
- •Not currently receiving, nor having received, any preventive treatment for myopic progression in the 12 months prior to inclusion (orthokeratology, soft defocus contact lenses, low-concentration atropine eye drops, corrective spectacles with peripheral defocus)
- •Myopic progression of at least -0.25 D in at least one eye during the year prior to inclusion (measurements documented by autorefractometer, with or without cycloplegia, or via previous optical prescriptions) or documented progression of axial length of +0.1 mm during the year prior to inclusion
- •Primary optical correction via spectacles (occasional use of contact lenses if applicable) or agreement to wear spectacles for at least 12 hours a day, every day
- •Enrolled in or a beneficiary of a social security scheme
- •Signed informed consent to participate in the study by the adult patient or by a person with parental authority for minor patients
排除标准
- •Confirmed syndromic myopia or findings suggestive of syndromic myopia
- •Obvious strabismus or significant heterophoria
- •Corrected visual acuity < 8/10 in at least one eye
- •A history of eye surgery (excluding eyelid surgery) in at least one eye
- •Hyperopia or non-myopic astigmatism
- •Anisometropia, i.e. a marked difference in correction between the two eyes
- •Advanced retinal disease in at least one eye, such as myopic maculopathy
- •Specific visual impairments in at least one eye requiring personalised treatments other than conventional corrective lenses
- •Intolerance to optical corrections (conventional lenses or lenses with peripheral defocus)
- •Patients subject to legal protection measures
- •Pregnant or breastfeeding women
- •Participation in another interventional clinical trial (drug clinical trial)
研究组 & 干预措施
Essilor® Stellest® 2.0 myopia-slowing lenses
干预措施: Essilor® Stellest® 2.0 myopia-slowing lenses (Device)
standard lenses
干预措施: Standard lenses (Device)
结局指标
主要结局
Axial length
时间窗: 1 year
Axial length measured using the IOL Master® biometer
次要结局
- Spherical equivalent(1 year)
- pourcentage of changement in optical correction(2 years)