Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Number of FBGC (foreign body giant cells) (slitlamp examination)
研究概览
简要总结
On the day of surgery, the the eye with astigmatism of at least 0.75dpt receives a Vivinex XY1A , HOYA Surgical Optics GmbH and the second eye to be operated receives an XY1, HOYA Surgical Optics GmbH.
A complete biomicroscopic examination and visual acuity testing using autorefractometer, will be performed 1 week (7-14days), 6 weeks (30-60days) and 5 month (4-6months) postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
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
Vivinex XY1
Implantation of an intraocular lens Hoya Vivinex XY1
干预措施: Vivinex XY1 (Device)
Vivinex XY1A
Implantation of an intraocular lens Hoya Vivinex XY1A
干预措施: Vivinex XY1A (Device)
结局指标
主要结局
Number of FBGC (foreign body giant cells) (slitlamp examination)
时间窗: 5 months
The number of foreign body giant cells on the IOLs will be assessed.
次要结局
- Incidence of Monocytes (slitlamp examination)(5 months)
- Grade of Anterior Fibrosis (slitlamp examination)(5 months)
- PCO Score (slitlamp examination)(5 months)
- Anterior chamber reaction (slitlamp examination)(5 months)
研究者
Rupert Menapace
Clinical Professor
Medical University of Vienna