NCT06333028已完成不适用
A Non-interventional, Prospective, Multicenter, Single Arm, Post-Marketing Clinical Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 7
- 主要终点
- Mean binocular BCDVA (logMAR) at Visit 1
研究概览
简要总结
A Study to Evaluate the enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction
详细描述
A Non-interventional, Prospective, Multicenter, Single Arm, Post-Marketing Clinical Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
- •Subjects with a post operative BCDVA of 20/40 or better.
- •Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB) approved ICF and authorization as appropriate for local privacy regulations and willing and able to comply with the follow-up study visit.
- •Subjects implanted bilaterally with enVista Aspire EA IOLs, powers ranging from + 6 to + 34.0 D, prior to enrollment into the study on or after 1 November
- •All subjects with a visually significant PCO (BCDVA worse than 20/40) who undergo a YAG capsulotomy may be enrolled 30 days post YAG procedure and with a postoperative BCDVA 20/40 or better.
排除标准
- •Subjects with any serious ocular pathology or underlying systemic medical disease (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, could confound the results of the study.
- •Subjects for whom a Toric IOL is indicated to achieve emmetropia.
- •Subjects for whom monovision treatment is planned.
结局指标
主要结局
Mean binocular BCDVA (logMAR) at Visit 1
时间窗: Day 60 to Day 270 after second eye implantation
Mean binocular best-corrected distance visual acuity (BCDVA) (logMAR) at Visit 1. Photopic BCDVA measured at 4 meters.
次要结局
未报告次要终点
研究者
研究点 (7)
Loading locations...
相似试验
招募中
不适用
Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle GlaucomaPrimary Open Angle GlaucomaNCT05564091Nova Eye, Inc.78
已完成
不适用
A Randomised Evaluation of Visual Function After Bilateral Implantation of Two Types of Presbyopia-correcting IOLsCataractPresbyopiaNCT03117426Maastricht University Medical Center30
已完成
不适用
Surgical Outcomes After Routine Cataract Extraction & Implantation of a Conventional or Spheric Intraocular LensCataract ExtractionNCT00366496Medical University of South Carolina30
已完成
不适用
Efficacy of multifocal intraocular lens in cataract surgerycataractJPRN-UMIN000006628Shinshu University Ophthalmology30
已完成
4 期
Visual Outcomes After Implantation of a New Multifocal Intraocular LensCataractNCT01505816Hospital Oftalmologico de Brasilia40