Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric Intraocular Lens (IOL)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years or older;
- •need spherical correction between 10-30 Diopters (D);
- •corneal astigmatism less than 0.75D as measured by keratometry;
- •willing to sign an Informed Consent Form and complete all visits;
- •pupil dilation greater than 6mm;
- •expected Visual Acuity (measured in logMAR)=0.3 or better
排除标准
- •Women of childbearing potential;
- •irregular corneal astigmatism;
- •keratopathy/keratectasia;
- •cornea inflammation or edema;
- •cornea reshaping surgery;
- •corneal dystrophy;corneal transplant;
- •amblyopia;
- •glaucoma;
- •Retinal Pigment Epitheliopathy (RPE)/Macular changes;
- •proliferative diabetic retinopathy
结局指标
主要结局
Visual Acuity
时间窗: pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery
Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
次要结局
- Spectacle Independence(pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery)