ISRCTN36732601进行中（未招募）2 期
Myopia Outcome Study of Atropine in Children (MOSAIC): a randomised controlled trial
Technological University of Dublin0 个研究点目标入组 250 人开始时间: 2017年10月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32002514 protocol (added 03/02/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 16/07/2018:
- •1. Between 6-16 years old of either gender
- •2. A spherical equivalent refractive error of -1.0D or worse
- •3. Myopic progression of at least -0.50DS over the last year
- •4. Astigmatism less than or equal to -2.50D
- •5. An intraocular difference in spherical equivalent <= 1D
- •6. Corrected visual acuity better or equal to logMAR 0.2 ?in both eyes
- •7. A difference between non-cycloplegic and cycloplegic spherical refraction of less than 1.00 D
- •8. Normal IOP (<= 21mmHg)
- •9. Normal ocular health
- •10. Good general health with no history of cardiac/respiratory diseases
- •11. Be willing to commit to the 2 year clinical trial as well as randomisation to the placebo
- •Previous participant inclusion criteria:
- •1. Between 6-16 years old of either gender
- •2. A spherical equivalent refractive error of -1.0D or worse
- •3. Myopic progression of at least -0.50DS over the last year
- •4. Astigmatism less than or equal to -1.50D
- •5. An intraocular difference in spherical equivalent <= 1D
- •6. Corrected visual acuity better or equal to logMAR 0.2 ?in both eyes
- •7. A difference between non-cycloplegic and cycloplegic spherical refraction of less than 1.00 D
- •8. Normal IOP (<= 21mmHg)
- •9. Normal ocular health
- •10. Good general health with no history of cardiac/respiratory diseases
- •11. Be willing to commit to the 2 year clinical trial as well as randomisation to the placebo
排除标准
- •1. Any ocular or systemic condition affecting vision or refractive error or where atropine is contraindicated
- •2. Any known allergy to atropine, cyclopentolate hydrochloride and/or proxymetacaine hydrochloride
- •3. Defective binocular vision, amblyopia or strabismus
- •4. Experienced previous pharmaceutical or optical myopia control interventions
- •5. If subjects (or parent/guardian) are unable to provide written informed consent
研究者
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