ChiCTR2100054139CompletedUnknown
评价两种环带柱镜调制镜片对延缓近视进展的安全性和有效性的临床试验
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- 眼轴长度
Study Overview
Brief Summary
通过与单光眼镜比较, 评估两种环带柱镜调制框架眼镜减缓近视进展安全性及有效性。
Study Design
- Study Type
- Interventional
- Primary Purpose
- 随机平行对照
- Masking
- 未说明
Eligibility Criteria
- Ages
- 6 to 13 (—)
- Sex
- All
Inclusion Criteria
- •1.年龄≥6 岁且≤13 岁，需经其监护人书面同意，性别不限；
- •2.双眼散瞳下客观验光等效球镜度均在-0.75D(含)至-5.00D（含）之间（基于客观验光检查的平均值），且左、右眼主觉验光最佳矫正视力大于或等于 1.0；散光小于等于 1.50D（参考散前主观验光），且等效球镜后双眼屈光参差≤1.50D；
- •3.自愿参加本临床试验，并签署知情同意书。
Exclusion Criteria
- •1.有过眼外伤或眼内手术史者；
- •2.临床上有意义的裂隙灯检查发现；
- •3.眼底检查结果≥2 级；
- •4.眼压异常（眼压＜10mmHg 或眼压＞21mmHg 或双眼眼压差≥5mmHg）；
- •5.合并有其他眼部疾病，如葡萄膜炎等各种炎症、青光眼、白内障、眼底病、眼部肿瘤、眼外伤、显性斜视患者；以及任何影响视功能的眼部病变；
- •6.患有全身性疾病造成免疫低下的患者（如急、慢性鼻窦炎，糖尿病，唐氏综合症，类风湿性关节炎，精神病患者或其他研究者认为不适合配戴框架眼镜等的疾病）；
- •7.3 个月内参加过药物临床试验者；
- •8.不能定期进行眼部检查者；
- •9.三个月内曾参与过任何近视控制临床研究试验，原先使用过或现在正在使用硬性角膜接触镜（含护理产品）、多焦接触镜、渐进多焦镜片等特殊设计近视控制镜、阿托品类药物等；
- •11.任意一只眼弱视；
- •12.研究者判定不能入选者。
Arms & Interventions
1 组
单光眼镜
3 组
环带柱镜调制框架眼镜 B（强离焦型）
2 组
环带柱镜调制框架眼镜 A（紧凑型）
Outcomes
Primary Outcomes
眼轴长度
Secondary Outcomes
- 睫状肌麻痹后客观验光等效球镜度
- 主觉验光结果
Investigators
Study Sites (1)
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