Post-Operative Axial Stabilty in Short and Long Eyes After Implanation of a Clareon Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- change in anterior chamber depth
研究概览
简要总结
Post operative intraocular lens position is being measured after cataract surgery in 34 patients with long and short eyes.
详细描述
Prediction of the post-operative IOL position in long and short eyes the prediction difficult. Therefore, it is relevant to evaluate the post-operative IOL position in patients with an axial eye length outside the typical range. This study will help to improve the prediction of the post-operative refractive outcome in short and long eyes after implantation of a Clareon IOL. Therefore, three different OCT based measurements will be used (IOLMaster700, CZM; CASIA II, Tomey; SM-39, CSO), respectively. Post-operatively, these measurements will be repeated 1 hour, 1 week, and 12 weeks after surgery.
Hypothesis: Implantation of the Clareon IOL leads to a stable post-operative IOL position in short (≤22.75mm) and long (≥25.50mm) eyes.
Endpoints:
Primary Endpoint: change in anterior chamber depth (=IOL position) in mm from 1 week to 12 weeks post-operative visit for both short and long eyes (two separate analysis) (Refraction will be a secondary outcome due to its larger variability compared to ACD measurements 1)
Secondary Endpoint:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bilateral cataract surger
- •axial eye length below 22,75mm or above 25.50mm
排除标准
- •ocular pathologies that could lead to an unstable capsular bag
- •pregnancy
- •preoperative visual acuity above 1.0logMar
结局指标
主要结局
change in anterior chamber depth
时间窗: 1 week and 12 weeks post operative
change in anterior chamber depth in millimeter
次要结局
- refractive outcome after intraocular lens implantation(1 week and 12 weeks post operative)