NL-OMON56071已完成不适用
A randomized controlled trial on the visual function after bilateral implantation of two novel Extended Depth-of-Focus intraocular lenses. - Vario-NL Study
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 32 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Minimum 18 years of age
- •- Bilateral cataract
- •- Bilateral implantation of either Acunex® Vario IOL or the Alcon AcrySof® IQ
- •Vivity® IOL
- •- Expected postoperative astigmatism <= 1.00 D (use of femtosecond laser
- •assisted cataract surgery (FLACS) astigmatic keratotomies (AKs) tolerated up to
- •1.5 D of corneal astigmatism preoperative)
- •- Bilateral implantation of a non-toric Acunex® Vario IOL or a non-toric Alcon
- •AcrySof® IQ Vivity® IOL
- •- IOL power calculation between +10.00 D and +30.0 D
- •- Expected postoperative best-corrected visual acuity of logMAR +0.3 or better
- •- Availability to undergo second eye surgery on the same day or else within 2
- •weeks of the first eye surgery
- •- Willing and able to comply with scheduled visits and other study procedures
- •- Signed informed consent
排除标准
- •- Previous corneal surgery and/or reshaping
- •- Corneal pathology (i.e., fuchs endothelial dystrophy (FED), irregular
- •astigmatism, herpes simplex virus (HSV) keratitis
- •- Extensive age-related macular degeneration (atrophic or exudative age-related
- •macular degeneration or numerous soft drusen) and post-intravitreal injection
- •- Extensive visual field loss (eg. glaucoma, cerebral vascular accident (CVA),
- •hemianopsia, etc.)
- •- Extensive diabetic retinopathy
- •- Amblyopia, strabismus, diplopia
- •- Pseudo exfoliation syndrome or other capsule or zonular abnormalities that
- •could affect postoperative centration or tilt of the IOL
- •- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or
- •pupils that do not dilate at least 3.5 mm under mesopic /scotopic conditions)
- •- Cognitive cerebral or concentration disorders (e.g., dementia, Parkinson,
- •stroke, etc.)
- •- Suturing of incision required at time of surgery
- •- Complications during surgery of the first eye.
研究者
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