NCT06102109招募中不适用
Long-term Results of Two Surgical Methods for Scleral IOL Implantation and Fixation in Eyes Without Capsular Support: Yamane- Versus 4-flanged Technique
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- IOL tilt
研究概览
简要总结
This study is a comparison of the surgical techniques and postoperative outcome between the two intrascleral IOL fixation techniques: Yamane technique versus the 4-flanged technique.
The main objectives are postoperative lens tilt, duration of surgery, intra- and postoperative complication rates and scleral integrity around the flanges.
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
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Necessity for IOL (re)fixation in the absence of capsular support
- •willing to give informed consent and follow-up the duration of study
排除标准
- •Anatomical or other contraindications for suture less IOL fixation, such as presence of a trabeculectomy bleb or scleromalacia
- •active inflammatory diseases of the eye
结局指标
主要结局
IOL tilt
时间窗: 3 years
The postoperative intra ocular lens tilt in degree measured by an anterior segment optical coherence tomography device (Casia 2, Tommy, Japan)
IOL decentration
时间窗: 3 years
The postoperative intra ocular lens decentration in millimetres measured by an anterior segment optical coherence tomography device (Casia 2, Tommy, Japan)
次要结局
- Best corrected visual outcome(12 weeks)
- Flange erosion and intrusion(3 years)
研究者
Claudette Abela-Formanek
Univ. Prof. Dr.
Medical University of Vienna
研究点 (2)
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