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临床试验/NCT07030153
NCT07030153招募中不适用

Genetic Variants and Their Association With Myopia Risk, Progression, and Optimal Interventions in Children

Beijing Visionly Plus Eye Hospital2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
2
主要终点
Polygenic Risk Score (PRS) for Myopia Progression

研究概览

简要总结

This study aims to identify genetic factors linked to myopia, including those that influence a person's risk of developing it and how quickly it progresses (like changes in eye length). It will also examine how different treatments-such as low-dose atropine drops, orthokeratology lenses, specialized glasses, and increased outdoor time-interact with these genes. Finally, the research will develop a genetic risk score to help tailor personalized myopia prevention and treatment plans.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 6-18 years.
  • Any Spherical equivalent refraction (SER)
  • Parental consent for genetic testing.

排除标准

  • Suspected genetic syndromes (e.g., Stickler, Marfan).
  • Other eye diseases (e.g., glaucoma, cataracts, retinal abnormalities, strabismus).
  • Prior refractive surgery

结局指标

主要结局

Polygenic Risk Score (PRS) for Myopia Progression

时间窗: Every 6 months for 3 years

1. Measure the Myopia Progression Rate (Change in Diopters/year) * Measurement Tool: Autorefractor (Topcon KR-8900) * Method: Spherical equivalent refraction (SER) will be measured at baseline and every 6 months, with the annual rate of change (ΔD/year) calculated. * Unit: Diopters (D) 2. Measure the Axial Length Growth Rate (mm/year) * Measurement Tool: Optical Biometer (Zeiss IOLMaster 700) * Method: Axial length (AL) will be measured at baseline and every 6 months, with the annual rate of change (Δmm/year) calcu 3. Genetic Risk Assessment Model * Measurement Tool: Candidate genetic loci will be screened using whole-exome sequencing (WES)or genome-wide association study (GWAS). * A PRS model for myopia progression will be constructed by integrating refractive error (SER) and axial length changes using LASSO, DBSLMM or LDpred2 regression. * The correlation between PRS and myopia progression rate will be evaluated (R² or AUC curve).

次要结局

  • Genotype-Guided Decision Tree for Myopia Control Interventions(Every 6 months for 3 years)

研究者

发起方
Beijing Visionly Plus Eye Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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