Prospective Multicenter Clinical Trial With the PRECIZON Presbyopic Multifocal Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ophtec BV
- 入组人数
- 70
- 试验地点
- 12
- 主要终点
- Improvement in monocular and binocular uncorrected and corrected distance visual acuity
研究概览
简要总结
The purpose of this clinical trial is to evaluate the effectiveness of the PRECIZON Presbyopic.
详细描述
Prospective, open-label, single-arm, multicenter clinical evaluation with a 3 months follow-up. The PRECIZON Presbyopic is a lens intended for implantation in the capsular bag, indicated for optical correction of aphakia in adults whom the crystalline lens has been removed and who desire presbyopia correction. The main objective is to evaluate the ability of the PRECIZON Presbyopic to provide near, intermediate and distance vision in patients undergoing cataract extraction / Clear Lens Exchange (CLE) and intraocular lens implantation. Study results will be used for CE-approval and registration and marketing purposes.
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
- 是
入选标准
- •Presbyopic
- •Cataract patient or Clear Lens Extraction (CLE) candidate
- •Patients wishes to be spectacle independent for near and far vision
- •Patient lifestyle and outlook fit with multifocal IOL implantation
- •Qualifies for bilateral implantation
- •Patient must have a calculated IOL power within the available diopter range
- •Expected best corrected visual acuity of 0.5 Snellen decimal or better after IOL implantation.
- •No secondary surgical procedure planned during the course of the study
- •Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study
- •Patients must provide written informed consent
- •The predicted keratometric postoperative astigmatism (calculated with respect to the surgical induced astigmatism) must be <1.0 D.
排除标准
- •Ocular disease other than cataract that may predispose for future complications or might confound the outcome of the investigation (e.g. anterior segment pathology, glaucoma, corneal dystrophy, ocular inflammation, pseudoexfoliation syndrome, retinal disorders)
- •Acute or chronic disease or illness or use of medication that could confound the outcome of the study or increase the risk to the subject
- •Endothelial cell count <1500 cells/mm2
- •Amblyopia
- •Congenital eye abnormalities
- •Previous ocular surgery that might confound the outcome of the investigation or increase risk to patient
- •Concurrent participation or participation during the last 30 days in any other clinical trial
- •Patient must not be pregnant or has another condition with associated fluctuation of hormones that could lead to refractive changes
结局指标
主要结局
Improvement in monocular and binocular uncorrected and corrected distance visual acuity
时间窗: 3 months post-op
The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide distance visual acuity
Improvement in monocular and binocular uncorrected and corrected intermediate visual acuity
时间窗: 3 months post-op
The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide intermediate visual acuity
Improvement in monocular and binocular uncorrected and corrected near visual acuity
时间窗: 3 months follow-up postoperative
The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide near visual acuity
次要结局
- Spectacle dependency(3 months post-op)
- Defocus curve(3 months post-op)
- Stability of manifest refraction (MRSE) as measured by a mean change in MRSE between visits as determined by a paired analysis(3 months post-op)
- Patient satisfaction as measured by a patient satisfaction questionnaire(3 months post-op)
- Quality of vision as measured by the Quality of Vision (QoV) questionnaire(3 months post-op)
- Photopic contrast sensitivity as measured by a contrast sensitivity chart(3 months postoperative)
- Mesopic contrast sensitivity as measured by a contrast sensitivity chart(3 months post-op)
- Rates of adverse events and complications(3 months post-op)