NCT07456488招募中2 期
The Effect of 0.01% Atropine Eye Drops on Axial Length and Refraction in Myopic Children Compared to a Control Group
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in axial length in mm
研究概览
简要总结
In this study, atropine 0.01% eye drops will be given to myopic children once at night daily for 6 months as compared to a control group to see the effect on axial length and refraction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-16 years
- •Both genders
- •Myopia of baseline SER of -1.00D or more
- •Astigmatism less than or equal to -2.50D
- •No medical history predisposing severe myopia (e.g., Marfan syndrome, Stickler syndrome, and retinopathy of prematurity), abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, and spherophakia)
- •No history of other vision-threatening ocular diseases or previous intraocular surgery.
- •No current or previous use of atropine or pirenzipine, contact lenses or other forms of treatment that may affect myopia progression.
排除标准
- •Astigmatism ≥ 2.5 D
- •Anisometropia>1 D
- •Best corrected visual acuity < 0.5 (6/12)
- •Prior intraocular surgery
- •Allergy to atropine eye drops
- •Systemic diseases associated with myopia such as Marfan syndrome, Stickler syndrome
- •History of cardiac or significant respiratory diseases
- •Lack of consent for participating in the study
研究组 & 干预措施
Group A
Active Comparator
Atropine 0.01% eye drops
干预措施: Atropine 0.01% eye drops (Drug)
Group B
No Intervention
No eye drops
结局指标
主要结局
Change in axial length in mm
时间窗: 6 months
Axial length is measured at the time of recruiting the participants and after the end of study
Change in refraction in Diopters
时间窗: 6 months
Refraction is measured at the start of study then after 6 months of study
次要结局
未报告次要终点
研究者
Hina Nadeem
Dr. Hina Nadeem, principal Investigator
Liaquat National Hospital & Medical College
研究点 (1)
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