Long-term Visual and Refractive Outcomes After Traumatic Cataract Surgery in Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
This prospective multicenter observational study aims to evaluate long-term visual and ocular biometric outcomes in pediatric patients aged 0-16 years who were diagnosed with traumatic cataract and underwent cataract extraction surgery. Medical records of eligible patients with at least 5 to 10 years of postoperative follow-up will be reviewed. Key outcome measures include best-corrected visual acuity (BCVA), axial length, corneal astigmatism, intraocular pressure (IOP), binocular function (fusion and stereopsis), intraocular lens (IOL) position, and postoperative complications. The study seeks to provide insight into long-term visual rehabilitation and prognostic indicators following pediatric traumatic cataract surgery.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 0 to 16 years at the time of trauma-related cataract diagnosis
- •Diagnosed with traumatic cataract (due to blunt or penetrating ocular trauma)
- •Underwent cataract extraction surgery with or without intraocular lens (IOL) implantation
- •Able to attend regular follow-up assessments for at least 5 years postoperatively
- •Written informed consent obtained from a parent or legal guardian
排除标准
- •Congenital or developmental cataract
- •Pre-existing ocular diseases unrelated to trauma (e.g., congenital glaucoma, retinal dystrophies)
- •Severe posterior segment damage precluding reliable visual outcome evaluation (e.g., endophthalmitis, choroidal rupture involving the macula)
- •Systemic or neurological disorders that affect vision or compliance with follow-up (e.g., cerebral palsy, intellectual disability)
- •Previous intraocular surgery in the affected eye unrelated to the trauma
研究组 & 干预措施
Traumatic cataract
Traumatic cataract
结局指标
主要结局
Visual Acuity
时间窗: From surgery up to 10 years postoperatively, depending on available follow-up duration
UDVA \& BCVA will be assessed using age-appropriate optotypes (e.g., Lea symbols, Snellen chart, or ETDRS chart) and recorded in logMAR units.
Axial Length Development
时间窗: From surgery up to 10 years postoperatively, depending on available follow-up duration
Axial Length(mm) measured by IOLMaster700
Corneal Astigmatism
时间窗: From surgery up to 10 years postoperatively, depending on available follow-up duration
Measured by Pentacam
次要结局
- Binocular Function(From surgery up to 10 years postoperatively, depending on available follow-up duration)
- Intraocular Pressure (IOP)(From surgery up to 10 years postoperatively, depending on available follow-up duration)
- Postoperative Complications(From surgery up to 10 years postoperatively, depending on available follow-up duration)
- Intraocular Lens (IOL) Position(From surgery up to 10 years postoperatively, depending on available follow-up duration)
- Anterior Chamber Depth (ACD)(From surgery up to 10 years postoperatively, depending on available follow-up duration)
- Lens Thickness (LT)(From surgery up to 10 years postoperatively, depending on available follow-up duration)
- White-to-White Corneal Diameter (WTW)(From surgery up to 10 years postoperatively, depending on available follow-up duration)
- Keratometry(From surgery up to 10 years postoperatively, depending on available follow-up duration)
研究者
Jin Yang
Chief Physician
Eye & ENT Hospital of Fudan University