Clinical Evaluation of the One-Piece Tecnis Multifocal IOL, Model ZMB00
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm
研究概览
简要总结
The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general postoperative outcomes of the One-Piece Tecnis Multifocal lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •bilateral cataracts and otherwise healthy eyes
- •visual potential of Decimal 0.8 in each eye
排除标准
- •any medications affecting vision
- •any chronic disease/illness that would affect risk to subject or outcomes of the study
- •any ocular pathology/abnormalities that may affect visual outcomes or confound study results
- •desire for monovision
研究组 & 干预措施
Monofocal Intraocular Lens
ZCB00 monofocal intraocular lens
干预措施: One-Piece Tecnis monofocal IOL, Model ZCB00 (Device)
Multifocal Intraocular Lens
ZMB00 multifocal intraocular lens
干预措施: One-Piece Tecnis Multifocal IOL (Device)
结局指标
主要结局
Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm
时间窗: 4-6 Months
Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group.
次要结局
- Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity(4-6 months)