ChiCTR2200064601Not yet recruiting治疗新技术临床试验
耳穴刺激联合 0.01%阿托品滴眼液控制儿童近视进展的随机对照临床研究
自筹1 site in 1 country240 target enrollmentStarted: July 1, 2022Last updated:
Trial Snapshot
- Phase
- 治疗新技术临床试验
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- 屈光度
Study Overview
Brief Summary
观察耳穴刺激联合 0.01%阿托品滴眼液在近视儿童中防控近视的临床效果。
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •散瞳验光之后屈光度-0.50～-6.00；
- •双眼散光≤-1.50D，双眼屈光参差≤1.50D；
- •双眼最佳矫正视力≥4.9；
- •眼前节、眼位、眼底、眼压检查正常，眼压 10-21mmHg；
- •患儿及监护人依从性好。
Exclusion Criteria
- •因遗传因素导致先天性近视情况；
- •伴有眼部器质性疾病（例如眼部感染、眼睑疾病、白内障、先天性视网膜疾病、斜视、弱视）、眼科手术史或全身性疾病；
- •耳廓畸形、耳部皮肤缺损、其他耳部疾病等不符合耳穴磁珠压贴开展指征；
- •曾有角膜塑形镜配戴史、低浓度阿托品滴药史、其他近视治疗史；
- •对耳穴胶带过敏、对阿托品药物过敏；
- •治疗依从性差、拒绝参与研究或中途脱落患者；
- •研究者判断其他可能影响临床研究进行及研究结果判定，不适合纳入研究的情况。
Arms & Interventions
组 1
框架眼镜
组 2
框架眼镜+阿托品滴眼液
组 3
框架眼镜+耳穴贴压
组 4
框架眼镜+阿托品滴眼液+耳穴贴压
Outcomes
Primary Outcomes
屈光度
Secondary Outcomes
- 眼轴长度
Investigators
Study Sites (1)
Loading locations...
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