EUCTR2010-021410-34-NL进行中（未招募）不适用
A double blind randomized study on the efficacy of cyclopentolate 1% and cyclopentolate 1% with tropicamide 1% in children - Efficacy of cycloplegics
Medical Centre Haaglanden0 个研究点目标入组 423 人开始时间: 2010年6月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 423
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patient is considered for the study when:
- •Good general health
- •Age 7 to 13 years
- •oGroup 4 - 8 of the Dutch primairy school system
- •Part I and II
- •Hypermetropia; e.g. > 0. 50 diopters in spherical equivalence (SEQ) values*
- •Good accommodation; e.q. > 10 diopters with dynamic retinoscopy
- •Sufficient reading capabilities
- •Best corrected distance visual acuity (BCDVA) of > 0.7 in each eye
- •Best corrected near visual acuity (BCNVA) of > 1.0 in each eye
- •Emmetropia or myopia in SEQ values
- •Isocoria and normal pupillary responses
- •* SEQ= sphere + cylinder:2
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Not healthy
- •Aged <6 and >13 year
- •Attending group 3 of the Dutch school system
- •Attending secondary school
- •Part I and II
- •Refractive errors < +0.50
- •Best corrected visual acuity of < 0.7 in one or both eye’s
- •Insufficient reading capabilities
- •Insufficient accommodation
- •Emmetropia or hypermetropia
- •An-isocoria or abnormal pupillary responses
研究者
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