Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Binocular Distance Corrected Intermediate Visual Acuity
研究概览
简要总结
The goal of this clinical trial is to compare the performance of 2 intraocular lenses (IOLs): ARTIS SYMBIOSE (study lenses) vs PANOPTIX (comparator) through binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative by a blinded evaluator.
This main objective will be to show superiority of the ARTIS SYMBIOSE system on the primary endpoint.
The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent.
Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits.
详细描述
This trial is a single center, prospective, randomized (1:1), unblinded, controlled study conducted in Germany according to Art. 82 MDR (PMCF study).
The lead investigator at the Heidelberg Eye University Hospital - International Vision Correction Research Centre (IVCRC) is Pr. Gerd Auffarth.
This study examines the visual performance of the two IOLs involved : Artis Symbiose (study lenses) compared to PanOptix (comparator) in bilaterally implanted patients.
The aim of this comparative study is to assess the performance and safety of these two IOLs with targeting to demonstrate the superiority of Artis Symbiose in some specific performance parameters. The tested hypothesis is the superiority of Artis Symbiose over PanOptix IOLs on the primary evaluation criterion.
A total of 50 patients will be included at one investigational center. Subjects participating in the study will attend a maximum of 5 study visits (1 preoperative, 1 operative and 3 postoperative visits) over a period of 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative is perforemd by a blinded evaluator.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 < Age < 85 years old
- •Bilateral age-related cataract
- •Signed informed consent of the study
- •Availability, willingness and sufficient cognitive awareness to comply with study procedures
- •No previous refractive or ocular surgery
- •Need for IOL in this diopter range: 10 to 30 D
- •Expected postoperative astigmatism ≤ 0.75 D
- •Eye dryness ≤ 2 in dry eye severity grading
- •For women of childbearing potential: Willing to adhere to an adequate form of contraception.
- •Non-inclusion criteria :
- •Being under guardianship / curatorship
- •Illiterate or not enough knowledge of German language
- •Acute or chronic disease or illness that would increase risk or confound study results found to be relevant by the investigators
- •Pupil > 4mm or < 2mm in photopic conditions
- •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
- •Occupation requiring night-time driving or any occupation incompatible with multifocality
- •Amblyopia, strabismus, color blindness
- •Extremely shallow anterior chamber
- •Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, uveitis, Marfan's syndrome)
- •Irregular astigmatism, unstable cornea
- •Pregnant or women of childbearing potential or breastfeeding women
排除标准
- •Patient consent withdrawal
- •Inability to place the intraocular lens safely at the location planned.
- •Surgical complications (e.g. non-circular rhexis, oversized or undersized rhexis). Each patient with these intraoperative complications should not be implanted with the study IOL.
结局指标
主要结局
Binocular Distance Corrected Intermediate Visual Acuity
时间窗: one month
The primary endpoint is Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions minimum 1-month post-operative by a blinded evaluator
次要结局
未报告次要终点