Development of a Database (Register) for Quality Assurance and Optimization of the Postoperative Results of Premium Intraocular Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 4
- 主要终点
- Monocular Best corrected distance visual acuity (5 m)
研究概览
简要总结
Short and long-term analysis of the refraction correction and optical image quality of modern premium intraocular lenses (IOLs) with the establishment of a database for quality assurance and optimization the computation constants of the lens power.
详细描述
Since the investigational lens, like conventional IOLs, is a posterior chamber lens which is widely implanted following cataract extraction, phacoemulsification is adopted. To assess the binocular vision, the investigational lens will be mono- or bilaterally implanted.
Clinically retro- and prospective, non-randomized, uncontrolled, open study at several centers: University Eye Clinic Heidelberg (leading center), Practice Center Ahaus in the Eye Clinic Ahaus, Breyer, Kaymak & Klabe Eye Surgery in Düsseldorf, nordBLICK Eye Center Kiel.
Main objectives:
- Functional results (refraction and visual acuity results) Secondary goals:
- Deviation target vs. achieved postoperative refraction (for constant optimization of the IOL calculation)
- Subjective patient satisfaction
- Visual quality (e.g. scattered light, contrast vision, spherical aberrations)
- Stability of the results achieved postoperatively
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- •Bilateral implantation of one of the following IOL models
- •Alcon PanOptix (TFNT00)
- •PhysIOL FineVision (POD F)
- •PhysIOL FineVision (POD F GF)
- •Uneventful cataract surgery with first clinical outcomes in the expected range
- •Patient included in Premium IOL study protocol by signed informed consent
排除标准
- •Age of patient <45 years
- •Irregular astigmatism
- •Postoperative manifested astigmatism of >1.0 D
- •Difficulty for cooperation (distance from their home, general health condition)
- •Clinically significant glaucoma
- •Clinically significant macular degeneration, clinically significant macular edema or proliferative diabetic retinopathy
- •Patients with keratoconus or keratectasia
- •Any ocular comorbidity having a significant effect on the postoperative clinical outcomes
- •History of ocular trauma or prior ocular surgery including refractive procedures
- •Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
- •Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
- •Intraoperative complications like capsular rupture etc.
- •Patients who do not give informed consent
研究组 & 干预措施
Experimental: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation
PhysIOL POD F GF: 50 (bilateral implantation) PhysIOL POD F: 50 (bilateral implantation) Alcon PanOptix: 20 (bilateral implantation) In this study, patients have already received treatment, after receiving the consent, the routinely collected pre-, intra- and postoperative data will be pseudonymized and evaluated.
干预措施: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation (Device)
结局指标
主要结局
Monocular Best corrected distance visual acuity (5 m)
时间窗: Postoperative Day 75-105 (3 months)
CDVA measured with ETDRS charts placed in 5m distance with best aided corrective glasses according to ISO 11979-7:2014.
次要结局
未报告次要终点