Positional Stability and Refractive Behaviour After In-the-bag Implantation of an Aspheric Hydrophobic IOL After Conventional Phacoemulsification and Femtosecond Laser-Assisted Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Tilt and decentration of intraocular lens measured in degrees
研究概览
简要总结
The newest generation Lucia 621 has a step vault design that is claimed to provide excellent positional and refractive predictability.
In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.
详细描述
In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.
Furthermore, the refractive outcome of CT Lucia 621P/PY is examined, providing optimized (en bloc optimization) formula constants for both, conventional and femtosecond-laser assisted cataract surgery for Haigis, Hoffer Q, Holladay I, SRK/T and Castrop formulae.
Besides ACD, further parameters for IOL stability are examined (IOL tilt/decentration) and consequences for the aberration profile are described.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subject with a minimum age of 22 years
- •Planned natural lens replacement with posterior chamber IOL implantation
- •Clear intraocular media other than cataract
- •Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit
- •Ability to consent to the participation in study
- •Signed informed consent
排除标准
- •Corneal pathology/ectasia
- •Prior ophthalmic surgery
- •Zonular-defects, unstable bag
- •Macular pathologies
- •Expected Visual acuity of less than 0.63 (decimal)
- •Use of systemic or ocular medication that might affect vision
- •Patient is pregnant, plans to become pregnant, is lactating
- •Concurrent participation in any other clinical trial with an investigation product
结局指标
主要结局
Tilt and decentration of intraocular lens measured in degrees
时间窗: 1 month post surgery compared with 12 months post surgery
Tilt and decentration of intraocular lens measured in degrees with Casia-2 Anterior Segment Optical Coherence Tomography 1 month post surgery compared with 12 months post surgery
次要结局
未报告次要终点
研究者
Matthias Bolz
Univ.-Prof. Dr.
Johannes Kepler University of Linz