Capsule Bag Performance of a Novel Single-piece Acrylic IOL HOYA AF-1 NY-60
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Anterior chamber depth
研究概览
简要总结
During the past decades, cataract surgery underwent tremendous change and modernisation resulting in today's small incision, phacoemulsification surgery and a safe technique with a short rehabilitation time for the patient.
In this study the capsule performance and stability of a new one-piece microincisional hydrophobic acrylic IOL (HOYA AF-1 NY-60) should be assessed in subgroups of normal, short and long eyes. The IOL has a sharp optic edge design to inhibit PCO formation. Hypothesis: The novel haptic design is supposed to avoid tension folds in capsule bag, allow for a longer contact length of haptic with capsule equator, ensure rotational stability as well as good centration of the optic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age-related cataract
- •Age 21 and older
- •Visual Acuity > 0.05
- •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
排除标准
- •Relevant other ophthalmic diseases especially those that may compromise capsule bag integrity or zonule stability (such as pseudoexfoliation syndrome, Marfan's syndrome, etc.)
- •Preceding ocular surgery or trauma
- •In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
结局指标
主要结局
Anterior chamber depth
时间窗: 4 times, each 5 minutes during procedure
Anterior chamber depth
时间窗: 4 times, each 5 minutes during procedure
次要结局
未报告次要终点
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Vienna Institute for Research in Ocular Surgery