Controlling Myopia Progression With Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Spherical Equivalent Refraction
研究概览
简要总结
This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.
详细描述
The study will be a prospective, randomized, single blind, bilateral dispensing study
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 (Investigator)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myopic subjects between 8 and 12 years of age.
- •The subject best sphere contact lens correction must lie between -0.75D (best of the two eyes) and -5.00D (worst of the two eyes)
- •Astigmatism must be less than or equal to 1.00D
- •1.00D or less difference in spherical equivalent between the two eyes
- •The subject must have a best-corrected visual acuity of 0.8+2 (20/25+2) and spherical equivalent refraction visual acuity of 0.820/25) or better in both eyes
- •The subject must have at least 8D of accommodation
- •The subject and subject's parent or legal guardian must read and sign the STAEMENT OF INFORMED CONSENT
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
排除标准
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with 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)
- •Anisometropia of greater than 1.00D
- •Astigmatism of greater than 1.00D in either eye
- •Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
- •Pervious refractive surgery, rigi contact lens wear, orthokeratology, keratconus or other corneal irregularity in either eye.
- •Strabismus in either eye
- •Pupil orr 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
- •Surgically altered eyes, ocular infection of any type, ocular inflammation
- •Subject has anterior chamber angle grade 2 or narrower
研究组 & 干预措施
Test Lens 1
Investigational soft contact lenses worn daily.
干预措施: Test Lens 1 (Device)
Test Lens 2
Investigational soft contact lenses worn daily.
干预措施: Test Lens 2 (Device)
Control lens
Spectacle lenses worn daily.
干预措施: Control Lens (Device)
结局指标
主要结局
Spherical Equivalent Refraction
时间窗: Baseline and every 6 months post-baseline for 2 years
Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia.
Axial Length (Axial Elongation)
时间窗: Baseline and every 6 months post-baseline for 2 years
Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up.
次要结局
未报告次要终点