NCT06111222已完成不适用
Multicentric Prospective Study on the Visual Performance of Patients Implanted With a Multifocal Intraocular Lens
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 6
- 主要终点
- Mean monocular best-corrected distance visual acuity (CDVA)
研究概览
简要总结
The goal of this clinical trial is to learn about the visual performance of a new multifocal intra-ocular lens in patients presenting for cataract or refractive lens exchange surgery. The main question it aims to answer is: What is the visual performance and patient satisfaction twelve months post-operatively? Participants will receive bilateral implantation of the investigational device, undergo post-operative assessments, and provide feedback on their overall visual satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older;
- •Patients scheduled for bilateral AT ELANA 841P phacoemulsification cataract extraction or Femtosecond-Laser-Assisted-Cataract-Surgery (cataract grades of 1, 2, 3 on the LOCSIII scale) and IOL implantation (Cataract or PRELEX) with a maximum of 28 days between both implantations; Calculated IOL power within the limited IOL Diopter range of +15.0D to +27.0D
- •No visual acuity limiting pathologies other than cataract;
- •Corneal Astigmatism of <1.0 D;
- •Availability, willingness, and sufficient cognitive awareness to comply with examination procedures;
- •Written informed consent for participation in the study and data protection.
排除标准
- •Corneal Astigmatism of ≥1.0 D;
- •Difficulty for cooperation (distance from their home, general health conditions);
- •History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, OHT, glaucoma suspect, glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.);
- •Visual field loss which has an impact on visual acuity;
- •Use of systemic or ocular medication that might affect vision;
- •Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus;
- •Pupil abnormalities (non-reactive, tonic pupils, abnormal myosis or mydriasis, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions);
- •Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome);
- •Cataract grades of 4, 5 or 6 on the LOCSIII scale ;
- •Surgeries with incision size of ≥2.75mm ;
- •Immediate Sequential Bilateral Cataract Surgery ;
- •Concurrent participation in another device investigation;
- •Usage of contact lenses during participation.
研究组 & 干预措施
Bilateral implantation of investigational device
Other
Bilateral implantation of investigational device
干预措施: AT ELANA (Device)
结局指标
主要结局
Mean monocular best-corrected distance visual acuity (CDVA)
时间窗: Three (3) Months
The objective is to evaluate Corrected Distance Visual Acuity (CDVA)
次要结局
- Refractive Predictability / Manifest Refraction and Prediction Error(Twelve (12) Months)
研究者
研究点 (6)
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