Toric Intraocular Lens Implantation in Pediatric Aphakia (Ages 3-8 Years): A Prospective Nonrandomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- BCVA at 3 years after surgery
研究概览
简要总结
Here, we conducted a nonrandomized clinical trial aims to evaluate and compare the prognosis of visual function in children of these two types of IOL implantation over a three-year postoperative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The data analysts and investigators who observed patient outcomes during follow-up were blinded to minimize bias
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 3 to 8 years and diagnosed as pediatric cataract; 2) at least 2.0 D of regular corneal astigmatism.
排除标准
- •history of ocular comorbidities such as such as glaucoma, retinal detachment, persistent fetal vasculature, and any retina-related pathologies; 2)history of ocular trauma or surgery; 3) concurrent severe systemic diseases; 4) lack of cooperation with slit-lamp examination, pentcam, IOL master700, subjective manifest refraction and other eye examinations.
研究组 & 干预措施
toric group
Name of Intervention: Implantation of AcrySof IQ Toric Intraocular Lens (IOL) SN6AT3-T9 Manufacturer: Alcon Laboratories, Inc.
Details of Intervention:
The intervention involves the surgical implantation of a toric intraocular lens (IOL) in pediatric cataract patients. This specific IOL model (SN6AT3-T9) is designed to correct astigmatism.
干预措施: Toric IOL implantation (Device)
non-toric group
Name of Intervention: Implantation of AcrySof IQ Hydrophobic Acrylic Intraocular Lens (IOL) SN60WF Manufacturer: Alcon Laboratories, Inc.
Details of Intervention:
The control intervention involves the surgical implantation of a non-toric, hydrophobic acrylic intraocular lens (IOL) in pediatric cataract patients. This IOL model (SN60WF) provides clear vision but does not correct pre-existing corneal astigmatism.
干预措施: Non-toric IOL implantation (Device)
结局指标
主要结局
BCVA at 3 years after surgery
时间窗: 3 years after surgery
次要结局
- UDVA(Postoperative 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years.)
- CDVA(Postoperative 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years)
- IOP(Postoperative day 1, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years)
- Axial length(Postoperative 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years)
- stereopsis(Postoperative 6 months, 1 year, 2 years, and 3 years)
- residual astigmatism(Postoperative 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years)
- Corneal astigmatism(Postoperative 1month, 3 months, 6 months, 1 year, 2 years, and 3 years.)
- spherical equivalent(Postoperative 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years.)
- IOL rotation(Postoperative 1 week, 2 weeks, and 1 month.)
研究者
Jin Yang
Professor
Eye & ENT Hospital of Fudan University