NCT05340699Unknown不适用
Safety and Efficacy of Defocus Distributed Multi-point Lens in Myopia Control
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Changes in Objective cycloplegic refractive
研究概览
简要总结
Evaluate the safety and effectiveness of experimental group by comparing with the control group
详细描述
Compared the experimental group with the control group,the safety and effectiveness of DDM lens in mtopia control will be evaluated.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 6-13,with written consent of his/her guardian,regardless of gender;
- •Objective cycloplegic spherical equivalent refractive between -1.00D and 5.00D,and best corrected vision acuity of right and left eyes are better than or equal to 1.0;
- •Astigmatism less than or equal to -1.50D;
- •Voluntarily participate in the clinical trial and sign the informed consent.
排除标准
- •Those with a history of ocular trauma or intraocular surgery;
- •Clinical significant slit-lamp findings;
- •Abnormal IOP(<10 mmHg , >21 mmHg or difference between two eyes >5mmHg);
- •Patient with other eye diseases,such as uveitis and other inflammation,glaucoma,cataract,fundus disease,eye tumors,eye trauma,strabismus and any lesions that affect vision function;
- •Patient with systemic diseases causing immunosuppression,such as acute or chronic sinusitis,diabetes,Down syndrome,rheumatoid arthritis,psychosis and other conditions that the investigator considers inappropriate for wearing glasses;
- •Those who have participated in other drug clinical trials within 3 months;
- •Only one eye meets the inclusion criteria;
- •Those who cannot have regular eye examinations;
- •Those who have been involved in any myopia control clinical trials,previously used or are using RGP,contact lens and glasses or atropine drugs to control myopia in the past year;
- •The candidates determined by the investigator are not eligible.
结局指标
主要结局
Changes in Objective cycloplegic refractive
时间窗: baseline, 12 months
Changes in objective cycloplegic refractive from baseline between two groups
Changes in Axial Length
时间窗: baseline, 12 months
Changes in axial length from baseline between two groups
次要结局
- Changes in near point of convergence(baseline, 6 months，18 months and 24 months)
- Changes in Objective cycloplegic refractive(baseline, 6 months，18 months and 24 months)
- Changes in amplitude of accommodation(baseline, 6 months，18 months and 24 months)
- Changes in Axial length(baseline, 6 months，18 months and 24 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to MethotrexateRheumatoid ArthritisNCT01587989Hoffmann-La Roche77
已完成
2 期
Light Dose Ranging Study of Photodynamic Therapy (PDT) With Levulan + Blue Light Versus Vehicle + Blue Light in Severe Facial AcneAcne VulgarisNCT00706433DUSA Pharmaceuticals, Inc.266
已完成
2 期
Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of MigraineAcute MigraineNCT02745392Zosano Pharma Corporation365
已完成
不适用
Safety and Effectiveness Study of Prodisc to Spinal Fusion SurgerySpinal DiseasesNCT00295009Synthes USA HQ, Inc.852
终止
3 期
Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy TubesOtitis Media in Patients With Tympanostomy TubesNCT01994642Par Pharmaceutical, Inc.203