NCT01292629已完成不适用
Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 5
- 主要终点
- Visual Acuity
研究概览
简要总结
The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.
详细描述
This study evaluated the safety and effectiveness of the Hoya Surgical Optics iSert Model 251 IOL following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. Results from this prospective, multicenter clinical trial will be used to support a PMA supplement for the iSert® 251 IOL.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
- •Have clear intraocular media
- •Have potential Best Corrected Visual Acuity of 20/40 or better
- •Have preoperative Best Spectacle-Corrected visual acuity of 20/40 or worse
排除标准
- •Have ocular pathology or abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
- •Are monocular
- •Have current ocular infection
- •Are taking systemic steroids or other anti-metabolites
- •Have previous retinal detachment in the operative eye or expect to require retinal laser treatment during the course of the study
- •Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.
研究组 & 干预措施
Investigational intraocular lens
Experimental
iSert 251 intraocular lens
干预措施: iSert 251 intraocular lens (Device)
结局指标
主要结局
Visual Acuity
时间窗: 4 to 6 months
BEST Spectacle-Correction (ETDRS) Distance Visual Acuity
次要结局
- Complications and Adverse Events(4 to 6 months)
研究者
研究点 (5)
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