Evaluating Interventional Modalities to prevent progression of childhood myopia
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change in Spherical Equivalent Refractive error
研究概览
简要总结
This study hypothesizes that different interventional modalities will showcase varying efficacies in halting the progression of childhood myopia. The response to myopia control interventions can be influenced by multiple factors including age, gender, the severity of the baseline myopia, the presence of parental myopia, and patient compliance to the treatment. Additionally, myopia control strategies might have discernible effects on higher-order aberrations, retinal image quality, and contrast sensitivity at increased spatial frequencies in children diagnosed with myopia. An intriguing correlation is postulated between the progression rate of myopia and alterations in the parapapillary zones, suggesting these zones as promising biomarkers for tracking myopia advancement.
The primary aim of this study is to assess the efficacy of various interventional modalities in preventing the progression of childhood myopia. Concurrently, the research seeks to identify the specific factors that influence the response to these treatments. A significant part of the investigation will also focus on discerning the impacts of both myopia and its control interventions on parameters such as higher-order aberrations, retinal image quality, and contrast sensitivity at increased spatial frequencies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •5-15 year children with documented myopia progression of ≥0.5D/year, myopic refractive error -1 D to -6 D, Best corrected visual acuity 6/9 or better in both the eyes.
排除标准
- •Previously on myopia control intervention, history of ocular surgery, anisometropia (> 1D), high astigmatism (> -1.5D), children with strabismus, amblyopia, ocular pathology including poor ocular surface, corneal opacities, staphyloma etc., high astigmatism (> -1.5D), not willing to follow-up/giving consent.
结局指标
主要结局
Change in Spherical Equivalent Refractive error
时间窗: Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month.
次要结局
- Change in ocular biometric parameters (axial length, keratometry, Lens power)(Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month.)
- Change in amplitude of accommodation(Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month.)
- Change in pupil size(Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month.)
- Effect on higher order aberrations, retinal image quality and contrast sensitivity(Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month.)
研究者
Vinay Gupta
AIIMS New Delhi