NCT01279122Unknown4 期
Evaluation of Visual Outcomes of Monovision Patients Bilaterally Implanted With Nanoflex Intraocular Lenses
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Uncorrected Near Visual Acuity
研究概览
简要总结
The purpose of this study is to look at how well you see the Nanoflex Intraocular lens placed in your eye.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients at least 18 years of age.
- •Patients who have bilateral NanoFlex implantation at least 3 months previously.
- •No significant ocular pathology causing DCVA to be less than 20/25 or causing significant visual loss.
- •DCVA of 20/25 or better in both eyes.
- •Spherical equivalent in the dominant eye to be +/-.50 or less and in the non-dominant eye to be between-1.00 and -1.
- •Uncorrected VA in dominant eye 20/25 or better.
排除标准
- •History of ocular trauma or prior ocular surgery (minor ocular trauma is allowed such as small superficial corneal scar not effecting vision; some prior ocular surgery is allowable so long as it has not impacted visual acuity.
- •Amblyopia or strabismus, significant visual field loss, or posterior capsular opacifcation.
- •Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.).
结局指标
主要结局
Uncorrected Near Visual Acuity
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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