Investigating Comparative Efficacy of Myopia Control Strategies and Genetic Underpinnings: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
研究概览
简要总结
Background: Myopia (nearsightedness) is a growing global health concern, projected to affect 50% of the world population by 2050. Children with progressive myopia are at risk of serious ocular complications including myopic maculopathy, glaucoma, and retinal detachment. Low-dose atropine (0.05%) has shown efficacy in slowing myopia progression, and optical interventions such as bifocal spectacles may provide additional benefits by altering peripheral retinal defocus. Objective: This randomized controlled trial aims to compare the efficacy and effectiveness of atropine 0.05% monotherapy versus combination therapy (atropine 0.05% plus bifocal spectacles) in controlling myopia progression in children. Methods: Children aged 4-16 years with bilateral myopia (cycloplegic spherical equivalent between -1.00 D and -6.00 D) and documented recent progression (≥ -0.50 D in the preceding 12 months) will be randomized 1:1 to receive either atropine 0.05% eye drops once daily or atropine 0.05% plus bifocal spectacles. The primary outcome is change in spherical equivalent refraction over 12 months; the secondary outcome is change in axial length. Follow-up visits occur at 3, 6, 9, and 12 months. Conclusion: This study will provide evidence on whether adding bifocal correction to pharmacological therapy offers superior myopia control compared to atropine alone, informing clinical practice guidelines for pediatric myopia management.
详细描述
Study Design and Setting:
This is a prospective, randomized, parallel-group, controlled trial conducted at the Department of Ophthalmology, Mayo Hospital, Lahore, Pakistan. The study is designed and reported in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. The total study duration is 12 months, with follow-up assessments scheduled at 3, 6, 9, and 12 months after baseline.
Sample Size Calculation:
Sample size was determined using G*Power software (version 3.1.9.4). A two-tailed independent-samples t-test was assumed with α = 0.05 and power = 0.95. The allocation ratio N1/N2 was set to 1. To detect a clinically meaningful difference in myopia progression between groups, a total of 210 participants are required, with 105 participants allocated to each treatment arm.
Randomization and Masking:
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
- Single (Outcomes Assessor)
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 to 16 years
- •Bilateral myopia with cycloplegic spherical equivalent refraction between -1.00 D and -6.00 D in each eye
- •Documented recent myopia progression of ≥ -0.50 D over the preceding 12 months
- •Best-corrected visual acuity (BCVA) of at least 6/12 (Snellen) or equivalent in each eye
- •Parent or guardian able and willing to provide written informed consent
- •Child assent when applicable (age 7 years and above per institutional policy)
排除标准
- •Ocular conditions affecting myopia progression: strabismus, amblyopia, significant astigmatism (>2.50 D), anisometropia (>2.50 D), cataract, glaucoma, uveitis, or history of ocular surgery
- •Prior myopia-control treatment within 6 months (atropine, orthokeratology, multifocal contact lenses, pirenzepine)
- •Known allergy or hypersensitivity to atropine or spectacle materials
- •Systemic or neurodevelopmental disorders affecting cooperation or refractive development
- •Inability to obtain accurate axial length or cycloplegic refraction measurements
- •Parent or guardian refusal to provide informed consent
研究者
Dr Memoona Arshad
Associate Professor
University of Faisalabad