Five-Year Visual Function and Refractive Outcomes After Congenital Cataract Surgery: A Multicenter Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Visual Acuity
研究概览
简要总结
This prospective multicenter observational study aims to evaluate the 5-year visual function and refractive outcomes in children undergoing surgery for congenital cataract. Key outcomes include best-corrected visual acuity, stereopsis, refractive error, and axial length growth. The study will help identify long-term trends and prognostic indicators after early cataract intervention in pediatric patients.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of congenital cataract
- •Underwent cataract extraction before 1 year of age
- •Available for regular follow-up for at least 5 years postoperatively
- •Written informed consent from legal guardian
排除标准
- •Acquired cataract or traumatic origin
- •Associated ocular malformations (e.g., microphthalmia, coloboma)
- •Systemic syndromes affecting vision (e.g., Down syndrome)
- •History of secondary surgery affecting visual outcome
结局指标
主要结局
Visual Acuity
时间窗: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
UDVA and BCVA will be assessed using age-appropriate optotypes (e.g., Snellen chart, ETDRS chart, or Lea symbols) and recorded in logMAR units at the last available follow-up, with a minimum duration of 5 years postoperatively.
axial length
时间窗: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
AL
Refractive Error
时间窗: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Refractive Error
次要结局
- IOP(Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.)
- Corneal Curvature (K1 and K2) by Pentacam(Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.)
- Stereopsis(Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.)
- white to white(Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.)
- anterior chamber depth(Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.)
- Complications(Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.)
- Central Corneal Thickness (CCT)(Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.)
- Corneal Astigmatism Magnitude(Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.)
- Binocular Fusion Assessment(Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.)
研究者
Jin Yang
Chief Physician
Eye & ENT Hospital of Fudan University