Myopia Progression With Freeform Open Ring Myopia Control Spectacles Versus a Commercial Peripheral Plus Myopia Control Spectacle in Chinese Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- myopic progression in one year
研究概览
简要总结
This is a prospective, randomized clinical trial. There will be a total of 180 participants randomized into three groups, Group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (CML).
Group 2 - 60 participants will wear the Open Ring 1 (OR1) lens design. Group 3 - 60 participants will wear the Open Ring 2 (OR2) lens design. For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old.
All groups will be required to wear spectacles for all waking hours for 12 months. After 12 months, the control group participants wearing CML will be randomised to wear either OR1 or OR2 lens designs; the Group 2 participants will continue wearing the OR1 lens for a further 12 months. The Group 3 participants will wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The Investigator will not have access to this randomisation code until the trial is completed and final data analysis performed. The randomisation code for spectacles will be applied (and broken if required) by a study clinical coordinator, and clearly documented. The clinical coordinator and dispenser will not be masked from the study products. The study team will ensure that study participants are masked from the study products.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants enrolled in the trial must:
- •be aged between 6 to 12 completed years (6 and 12 years inclusive), irrespective of gender.
- •For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old.
- •be cycloplegic autorefraction spherical component -0.50 D to -4.00D, cylinder no more than -1.50D
- •be accompanied by parents/guardians who can read and comprehend Chinese and give informed consent as demonstrated by signing a record of informed consent.
- •be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
- •have ocular health findings considered to be "normal".
- •be correctable to at least 6/9.5 (20/30) or better in each eye with spectacles.
- •be willing to wear the spectacles provided by the investigators for all waking hours.
排除标准
- •Participants enrolled in the trial must NOT have:
- •a known allergy to, or a history of intolerance to tropicamide or topical anaesthetics.
- •had strabismus and/or amblyopia.
- •Anisometropia greater than 1.50D spherical equivalent
- •had previous eye surgery (including strabismus surgery).
- •any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes.
- •had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids.
- •current orthoptic treatment or vision training.
- •any anatomical, skin or other condition that would impact on the wearing of spectacles.
- •Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
- •Currently enrolled in another clinical trial.
- •No previous myopia management intervention or treatment within 3 months of enrolment
结局指标
主要结局
myopic progression in one year
时间窗: 12 months.
The primary outcome measure of this study is myopic progression in one year. This is expressed as the change in spherical equivalent refractive state from baseline levels. Spherical equivalent refraction will be taken as the mean of the spherical equivalent refraction of five, reliable, cycloplegic autorefraction measurements on each eye. Myopia progression is also expressed as the change in axial length from baseline levels. Myopia progression is characterised by ocular anatomical changes, the most notable being increased axial length. This will be measured at 6 monthly intervals.
次要结局
- myopia progression within myopia risk categories(12 months.)
- the wearer subjective experience(12 months.)