Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- IOL rotation degree at 12 months
研究概览
简要总结
This study included cataract patients who underwent intraocular lens (IOL) implantation with or without capsular tension ring (CTR), which aimed to evaluate the contribution of the use of CTR in clinical visual outcomes and rotational stability of IOL after cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •preexisting corneal pathology
- •small pupil
- •zonular dehiscence
- •a history of ocular trauma or surgery
- •intraoperative complications
结局指标
主要结局
IOL rotation degree at 12 months
时间窗: three months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Residual astigmatism (RAS) at two weeks
时间窗: two weeks
RAS after surgery, which was measured as manifest refraction at two weeks
Residual astigmatism (RAS) at one month
时间窗: one month
RAS after surgery, which was measured as manifest refraction at one month
IOL rotation degree at 1 week
时间窗: one week
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 2 weeks
时间窗: two weeks
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 1 month
时间窗: one month
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 3 months
时间窗: three months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at one hour
时间窗: one hour
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 1 day
时间窗: one day
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 3 days
时间窗: three days
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 6 months
时间窗: three months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
次要结局
- visual acuity (VA) at 3 months(three months)
- visual acuity (VA) at 6 months(six months)
- visual acuity (VA) at 12 months(twelve months)
- visual acuity (VA) at 1 day(two weeks)
- visual acuity (VA) at 1 weeks(two weeks)
- visual acuity (VA) at 2 weeks(two weeks)
- visual acuity (VA) at 1 month(one month)
- IOL tilt at 1 day(one day)
- visual acuity (VA) at 3 days(two weeks)
- IOL tilt at 3 days(three days)
- IOL tilt at 1 week(one week)
- IOL tilt at 6 months(six months)
- IOL tilt at 2 weeks(two weeks)
- IOL tilt at 1 month(one month)
- IOL tilt at 3 months(three months)
研究者
Jin Yang
Professor
Eye & ENT Hospital of Fudan University