NCT04230629Unknown不适用
Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
适应症
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
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
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