Myopia Progression After Ceasing Myopia Control Contact Lens Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Spherical Equivalent Refractive Error
研究概览
简要总结
This is a continuation study for subjects who were previously fit with test or control lenses; all will stop wearing their study lenses assigned in the previous study and will start to wear an FDA-approved marketed spherical soft contact lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must be enrolled in the parent protocol for at least one year.
- •The subject's parent or legal guardian must read and sign the STATEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
排除标准
- •Ocular or systemic allergies that may interfere with contact lens wear.
- •Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with contact lens wear.
- •Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
- •Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Any infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV)
- •Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study.
- •Strabismus.
- •Pupil or lid abnormality or infection in either eye
- •Central corneal scar in either eye
- •Aphakia in either eye
- •Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.
- •History of participation in prior clinical trials aimed to control myopia progression, except for the parent trial
- •Surgically altered eyes, ocular infection of any type, ocular inflammation.
- •Anterior chamber angle grade 2 or narrower by Van Herrick method.
研究组 & 干预措施
Test lens C
Test lens C from previous study
干预措施: 1 Day Acuvue Moist (Device)
Test lens A
Test lens A from previous study
干预措施: 1 Day Acuvue Moist (Device)
结局指标
主要结局
Spherical Equivalent Refractive Error
时间窗: Baseline and every 6 months up to 18 months
Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis.
Axial Length of the Eye
时间窗: Baseline and every 6 months post-baseline up to 18 months
Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis.
次要结局
未报告次要终点