NCT00838045已完成4 期
A Prospective, Multi-Center Clinical Investigation to Evaluate the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL (Model MI60) Intraocular Lens
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Bast Corrected Visual Acuity
研究概览
简要总结
This study is to evaluate the safety and effectiveness of the Bausch & Lomb Akreos TL (thin lens) intraocular lens (IOL) following implantation in adults requiring cataract surgery.
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
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
- •Subjects must be undergoing primary intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
- •Subjects must require a lens power from 15 to 30 diopters.
- •Subjects must have a visual potential of 20/40 or better in the study eye.
排除标准
- •Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- •Subjects with any inflammation or edema (swelling) of the cornea.
- •Subjects with uncontrolled glaucoma or glaucoma under current treatment in the study eye or with ocular hypertension.
- •Subjects with previous retinal detachment.
- •Subjects with diabetic retinopathy (proliferative or non-proliferative).
- •Subjects with rubella, bilateral congenital, traumatic, or complicated cataract.
- •Subjects who have had previous ocular surgery in the planned operative eye, excluding ocular adnexa surgery.
- •Subjects who have already received an Akreos TL IOL in the fellow eye.
结局指标
主要结局
Bast Corrected Visual Acuity
时间窗: 24 months
best-corrected visual acuity (BCVA)
次要结局
- Uncorrected Visual Acuity(24 months)
- Manifest Refraction(24 Months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere LensContact Lens WearNCT03897712Bausch & Lomb Incorporated84
Unknown
不适用
Evaluation of Efficacy and Long-term Safety for Lucidis Instant Focus© - PMCF Study ProtocolCataractNCT04761276SAV-IOL SA120
招募中
不适用
A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in ChildrenMyopiaNCT06305663Bausch & Lomb Incorporated418
已完成
不适用
LK Scleral Lens for Patients With Intractable Ocular Surface DiseasesOcular Surface DiseaseNCT04535388Seoul National University Hospital16
已完成
3 期
Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular LensCataractsPresbyopiaNCT02487160Lenstec Incorporated499