临床试验/NCT01544777

NCT01544777已完成不适用

Visual Quality Following Aspheric and Monovision Lens Implantation - a Comparative Clinical Study

Hoya Surgical Optics, Inc.2 个研究点分布在 1 个国家目标入组 42 人开始时间: 2012年2月最近更新: 2015年3月25日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Hoya Surgical Optics, Inc.
入组人数: 42
试验地点: 2
主要终点: Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate visual acuity and quality of vision in participants undergoing cataract surgery with a Hoya model 751 intra-ocular lens and to compare the visual results to the common monofocal lens in use.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Factorial
主要目的: Treatment
盲法: None

入排标准

年龄范围: 40 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Senile cataract
•Patient identified as a candidate for cataract surgery and IOL implantation
•Willing to sign informed consent document approved by the Ethical Committee
•Willing to complete all required tests and exams per this protocol

排除标准

•Amblyopia
•History or evidence of any ocular disease that may affect visual acuity
•Previous ocular surgery, including refraction surgery
•Ocular anomalies (e.g. microphthalmos, kerataconous)
•Subjects with greater than 1.0 D of corneal astigmatism
•Subjects who experience intraoperative complications that could affect postoperative IOL centration or tilt

结局指标

主要结局

Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near

时间窗: Up to 3 months

次要结局

未报告次要终点

研究者

发起方

Hoya Surgical Optics, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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