Cell Ongrowth and Biocompatibility Study of Two Different (Hydrophobic Acrylic) Intraocular Lenses: IOL XY1 vs. IOL XY1A
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Foreign Body Giant Cells
研究概览
简要总结
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
- •Age 40 and older
- •Astigmatism of at least 0.75Diopters in one eye
- •Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
排除标准
- •Diabetes mellitus
- •Pseudoexfoliation syndrome
- •Systemical anticoagulation
- •Antiphlogistic therapy
- •Antiglaucomatosa
- •Uncontrolled systemic or ocular disease
- •Preceding ocular surgery or trauma
- •Intraoperative complications
- •Pregnancy/Nursing
- •Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
研究组 & 干预措施
Toric vs Monofocal IOL
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm one (I) participants will receive a monofocal IOL (XY1) vs. an toric IOL (XY1A)
干预措施: cataract surgery (Procedure)
结局指标
主要结局
Foreign Body Giant Cells
时间窗: 6 weeks
The primary objective is to assess the difference in Foreign Body Giant Cells between monofocal and toric lenses in every patient at 6 weeks follow up.
次要结局
- Foreign Body Giant Cells(5 months)
- small round cells(5 months)
- PCO(5 months)
- anterior chamber reaction(5 months)
研究者
Christina Leydolt
Assoc. Prof. Priv. Doz. Dr.
Medical University of Vienna