The Effect of Myopia-Control Contact Lenses in New Zealand Chinese Children
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Mean Spherical Equivalent Cycloplegic Refraction
研究概览
简要总结
The study will employ a randomized, controlled, investigator-masked paired-eye comparison design to evaluate the effects of two myopia-control contact lenses-MiSight 1 Day and Abiliti 1-Day-in New Zealand Chinese children.
The study duration will be 12 months, with assessments conducted at baseline, 2 weeks, 3 months, 6 months and 12 months.
The clinical research will be conducted at the Auckland Myopia Clinic (New Zealand) and will follow a standard clinical routine for children with early myopia, the only difference being the randomizing of the MiSight and Abiliti contact lenses between the two eyes of the participants.
详细描述
- Study Design The study will employ a randomized, controlled, investigator-masked paired-eye comparison design to evaluate the effects of two myopia-control contact lenses-MiSight 1 Day and Abiliti 1-Day-in New Zealand Chinese children. The study duration will be 6 months, with assessments conducted at baseline, 2 weeks, 3 months, and 6 months. The clinical research will be conducted at the Auckland Myopia Clinic (New Zealand) and will follow a standard clinical routine for children with early myopia, the only difference being the randomizing of the MiSight and Abiliti contact lenses between the two eyes of the participants.
- Participants 2.1 Recruitment and Eligibility Criteria • Participants: 53-66 New Zealand Chinese children aged 7-11 years.
- Inclusion criteria:
o Spherical refractive error between -1.00D and -4.50D
o Astigmatism of ≤1.00D
o No history of orthokeratology or atropine use
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spherical refractive error between -1.00D and -4.50D
- •Astigmatism of ≤1.00D
- •No history of orthokeratology or atropine use
- •No ocular diseases or surgical history
排除标准
- •o No ocular diseases or surgical history
研究组 & 干预措施
Abiliti 1-Day
Commercially available myopia control contact lens
干预措施: Albiliti 1-Day (Johnson and Johnson, VisionCare) (Device)
MiSight Contact Lens
Commercially available myopia control contact lens
干预措施: MiSight Contact Lenses (CooperVision) (Device)
结局指标
主要结局
Mean Spherical Equivalent Cycloplegic Refraction
时间窗: Baseline, 2 weeks, 3 months, 6 months
The dioptric refractive error as determined by retinoscopy following cycloplegic refraction
Axial length
时间窗: Baseline, 2 weeks, 3 months, 6 months
Ocular biometry measured with Myah biometer
Mean Spherical Equivalent Cycloplegic Refraction
时间窗: Baseline, 2 weeks, 3 months, 6 months, 12 months
The dioptric refractive error as determined by retinoscopy following cycloplegic refraction
Axial length
时间窗: Baseline, 2 weeks, 3 months, 6 months, 12 months
Ocular biometry measured with Myah biometer
次要结局
- Children Dry Eye Questionnaire (CDEQ) response(Baseline, 2 weeks, 3 months, 6 months)
- Non-invasive Tear break-up time(Baseline, 2 weeks, 3 months, 6 months)
- Ocular Protection Index(Baseline, 2 weeks, 3 months, 6 months)
- Corneal punctate spots(Baseline, 2 weeks, 3 months, 6 months)
- Conjunctival punctate spots(Baseline, 2 weeks, 3 months, 6 months)
- Ocular Protection Index(Baseline, 2 weeks, 3 months, 6 months, 12 months)
- Corneal punctate spots(Baseline, 2 weeks, 3 months, 6 months, 12 months)
- Conjunctival punctate spots(Baseline, 2 weeks, 3 months, 6 months, 12 months)
- Children Dry Eye Questionnaire (CDEQ) response(Baseline, 2 weeks, 3 months, 6 months, 12 months)
- Non-invasive Tear break-up time(Baseline, 2 weeks, 3 months, 6 months, 12 months)