NCT04369482Unknown不适用
Posterior Capsule Opafication of Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs.Clareon IOL
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- PCO score
研究概览
简要总结
On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an Clareon, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type.
A complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for PCO evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 90 Years（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 has planned
- •Age 50 and older
- •Visual potential in both eyes of 20/30 or better as determined by investigators estimation
- •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
排除标准
- •Preceding intraocular surgery or ocular trauma
- •Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.)
- •Laser treatment
- •Uncontrolled systemic or ocular disease
- •Infectious disease
- •Pregnancy/Nursing
结局指标
主要结局
PCO score
时间窗: 3 years
subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO)
次要结局
- Visual Acuity(3 years)
- Subjective glistening score(3 years)
- Fibrosis(3 years)
- YAG capsulotomy rate(3 years)
研究者
Rupert Menapace
Clinical Professor
Medical University of Vienna
研究点 (2)
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