DRKS00026782已完成4 期
Prospective monocentric PMCF study after bilateral, combined implantation of a glistening-free, hydrophobic, rotationally asymmetric EDOF and multifocal intraocular lens based on the blended vision principle evaluating visual acuity and patient satisfaction - acumax-2020-03: Blended Vision Acunex Vario + Acunex VarioMax
Teleon Surgical B.V.0 个研究点目标入组 32 人开始时间: 2021年10月4日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 one（—）
- 性别
- All
入选标准
- •Patient age > 40 years
- •Bilateral cataract / bilateral intervention
- •Expected post-operative corneal astigmatism = 0.75 D
- •Planned implantation in the capsular bag
- •photopic pupil size between 3 and 6 mm
- •Pupil decentering <0.8 mm (center shift)
- •Contact lens wear within the last 2 weeks before screening
- •Presence of a written declaration of informed consent from the patient
排除标准
- •Amblyopia,
- •Strabismus
- •Pregnancy
- •Zonulolysis
- •Keratoplasty
- •Irregular Corneal Astigmatism
- •Previous corneal refractive interventions or surgical glaucoma interventions
- •Diseases other than cataract, which may result in postoperative, monocular best-corrected distance vision <0.63 (decimal visual acuity)
- •Intraoperative complications
- •The patient's current active participation in another clinical trial
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