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临床试验/NCT06265454
NCT06265454尚未招募2 期

Effect of Low Concentration Atropine Eye Drops on Choroidal Thickness, Central Corneal Thickness, Anterior Scleral Thickness and Axial Length in Myopic Children

Ain Shams University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
75
试验地点
1
主要终点
change in the average Choroidal Thickness over follow up period.

研究概览

简要总结

Previous Studies reported that low concentration atropine eye drops may be effective in increasing the choroidal blood flow and thickness and this slows myopia progression.

purpose of the study is to compare changes in axial length, anterior chamber depth, choroidal thickness, central corneal thickness and anterior scleral thickness among myopic children receiving atropine 0.05% or 0.01% and placebo.

详细描述

Myopia is the most common refractive error, and its prevalence rate is increasing worldwide, as per WHO, it is projected to increase from 22% in 2000 to 52% by 2050. It is more prevalent in developed, industrial areas and affects individuals of all ages (Singh et al., 2022). Myopia, especially the degenerative type, is associated with sight-threatening complications, including presenile cataract, glaucoma, retinal detachment, choroidal neovascularization, myopic macular degeneration, scleral and choroidal thinning (Sanchez-Cano et al., 2014 and Gupta et al., 2015) which makes myopia a major public health concern and finding an effective treatment to prevent myopia progression is critical (Wakazono et al., 2016).

Atropine is a nonselective muscarinic antagonist used for myopia control in previous studies. However, its actual mechanism of action is not well known (Yam et al., 2019).

But different mechanisms were described, first mechanism, that atropine may induce release of dopamine causing thickening of choroid (Nickla et al., 2010) Second mechanism,blockage of choroidal smooth muscle contraction through its anti-muscarinic action. Third one, increasing capillary permeability. Fourth, potentiating the synthesis and release of intraocular nitric oxide (Yam et al.,2022) also it stimulates retinal expression of the transcription factor ZENK which was considered an eye growth-inhibiting signal (Torii et al., 2017). All these mechanisms cause thickening of the choroid and increased choroidal blood flow which has been found to play a role in the regulation of eye growth and refractive error development through inhibition of the penetration of various retinal-derived growth factors that act as mechanical barriers and slow scleral growth (Nickla et al., 2015 & Guggenheim et al., 2011). Also, choroid can secrete growth factors that prevent scleral hypoxia (Wu et al., 2018).

According to the Low-concentration Atropine for Myopia Progression (LAMP) study, different atropine eye drops concentrations 0.05%, 0.025%, and 0.01% controlled myopia progression but the most effective concentration on spherical equivalent and axial length progression was 0.05% (Yam et al., 2019).

Zhang et al. reported in 2016 that administration of 1% atropine gel increased the choroidal thickness in young Chinese children with inhibition of eye growth.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age ranges from 6 to
  • Spherical equivalent ≥ -1.0 D.

排除标准

  • Astigmatism ≥ 3.0 D.
  • History of allergy to atropine or positive skin allergy test.
  • Ocular pathology otherwise myopia.
  • Recent ocular surgery.
  • Chronic systemic disease.
  • Use of rigid contact lenses or soft contact lenses for 1 week before participating in the study

研究组 & 干预措施

myopic children atropine 0.05%

Active Comparator

they will receive topical atropine 0.05% for 12 weeks and all investigations will be done before administration of atropine (baseline assessment), then after 1 month, 2 months, 3 months.

干预措施: low dose atropine eye drops (Drug)

myopic children atropine 0.01%

Active Comparator

they will receive topical atropine 0.01% for 12 weeks and all investigations will be done before administration of atropine (baseline assessment), then after 1 month, 2 months, 3 months.

干预措施: low dose atropine eye drops (Drug)

myopic children placebo

Placebo Comparator

they will receive placebo for 12 weeks and all investigations will be done before administration of placebo (baseline assessment), then after 1 month, 2 months, 3 months.

干预措施: Placebo (Drug)

结局指标

主要结局

change in the average Choroidal Thickness over follow up period.

时间窗: from enrollment till end of eye drops trial over 3 months and after stopping the drops for 3 months

Follow up of choroidal thickness during treatment period

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

aya mahmoud

Doctor

Ain Shams University

研究点 (1)

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