A Prospective, Randomization, Double-blind Study to Evaluate the Efficacy and Safety of Multifocal Soft Contact Lens in Myopia Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 3
- 主要终点
- Objective cycloplegic refractive error
研究概览
简要总结
The objective of this study is to investigate the efficacy and safety of soft lens in myopia control.
详细描述
This is a prospective, randomized, paired eye comparison, double-blind study aims to evaluate the efficacy and safety of "Soft Lens" in myopia control among schoolchildren. A total of 118 eyes are planned to be enrolled and the expect duration of subject participation will be 48 weeks not including two weeks of screening period. Data such as refractive error, axial length, visual acuity, average wearing hours, self-assessment, adverse events etc. will be collected during the study. A total of 10 visits, i.e. a screening visit, a randomization visit, and 8 treatment visits are planned. Subjects will be encouraged to complete all planned visits.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both genders aged between 6 and 15 years
- •Spherical equivalent refractive error between -1.00D and -10.00D
- •Visual acuity with contact lens of 20/25 or better in each eye
- •Astigmatism less than or equal to 1.50D
- •Anisometropia less than or equal to 1.00D
- •Agree to wear assigned contact lens and able to comply with the study protocol
- •Subjects and/or their legal representatives agree to sign informed consent form
排除标准
- •Eye disease or vision problem that may contraindicate/interfere with contact lens wearing, for example:
- •Severe strabismus at investigator's discretion
- •Pathologically dry eye
- •Slit lamp findings including but not limited to corneal edema, corneal ulcer, bulbar redness that are more serious than grade 1
- •Currently ocular infection of any type or inflammation in either eye
- •Oculomotor nerve palsies
- •Pupil or lid abnormality in either eye
- •Severe ocular allergy
- •Anterior segment infection, inflammation or abnormality
- •Corneal vascularization greater than 1 mm of penetration
- •History of herpetic keratitis
- •Use of bifocals, progressive addition lenses, rigid gas permeable contact lenses, orthokeratology lenses, atropine, pirenzepine or any other myopia control treatment within 1 month prior to screening visit
- •Systemic disease that may affect vision or contact lens wearing (e.g. diabetes, Down syndrome), autoimmune disease, infectious disease, or immunosuppressive diseases recorded in medical charts or informed by caregiver
- •Surgically altered eyes (e.g. corneal or refractive surgery, not including stye removal surgery)
- •Receiving any medication for long-term use which may interfere with contact lens wearing, tear film production, pupil size, accommodation or refractive state, such as nasal decongestants (e.g. pseudoephedrine, phenylephrine), antihistamines (e.g. chlorpheniramine, diphenhydramine), Prednisolone or Ritalin (methyphenidate)
研究组 & 干预措施
Group A
Intervention name: multifocal soft contact lens/single vision soft contact lens
Left eye: multifocal soft contact lens Right eye: single vision soft contact lens
干预措施: soft contact lens (Device)
Group B
Intervention name: multifocal soft contact lens/single vision soft contact lens
Left eye: single vision soft contact lens Right eye: multifocal soft contact lens
干预措施: soft contact lens (Device)
结局指标
主要结局
Objective cycloplegic refractive error
时间窗: 48 weeks
Changes in objective cycloplegic refractive error between the two eyes in 48 weeks
Axial length
时间窗: 48 weeks
Changes in axial length between the two eyes in 48 weeks
次要结局
- Cycloplegic refractive error(12, 24, and 36 weeks)
- Axial length(12, 24, and 36 weeks)
- Myopia progression and axial elongation(during 48 weeks)
- Self-assessment by questionnaire 1(during 48 weeks)
- Self-assessment by questionnaire 2(during 48 weeks)
- Self-assessment by questionnaire 3(during 48 weeks)