Prospective Research on the Intervention of Myoless2.0 Effectiveness (PRIME) in Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Myopic progression in one year
研究概览
简要总结
The Goal of the study is to evaluate the rate of myopia progression with open ring myopia control spectacle lens designs compared to a commercial peripheral plus myopia control spectacle lens (CML) in European children with myopia. This is a prospective, randomized, bilateral wear, double masked, cross-over 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 will continue wearing CML for a further 12 months; 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
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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 -6.00D, cylinder no more than -2.00D, and with a spherical equivalent greater than or equal to -6.00D.
- •Be accompanied by parents/guardians who can read and comprehend 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
- •A known allergy to, or a history of intolerance to cyclopentolate or topical anesthetics.
- •Had strabismus and/or amblyopia.
- •Cylinder more than -2.00D
- •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 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.
结局指标
主要结局
Myopic progression in one year
时间窗: At baseline, 3, 6, 12, 18 and 24 months
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 with a precision of 0.12D, measured in diopters (D). Myopia progression is also expressed as the change in axial length from baseline levels, measured in millimeters (mm). Myopia progression is characterized by ocular anatomical changes, the most notable being increased axial length, measured in millimeters (mm).
次要结局
未报告次要终点