Clinical Evaluation of a Modified Light Transmission IOL
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 11
- 主要终点
- Best Corrected Distance Visual Acuity
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of a new investigational modified light transmission monofocal intraocular lens compared to a conventional intraocular lens (IOL).
详细描述
The investigational IOL will be found to be safe and effective with respect to visual acuity, color vision, contrast sensitivity and complications and will be similar to results for the ZA9003 control eyes. Complication rates and adverse event rates will be within the FDA grid for posterior chamber IOLs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Age 18 years of age or older
- •Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned
- •Visual potential in both eyes of 20/30 Snellen or better after cataract removal and IOL implantation
- •Preoperative corneal astigmatism of 1.5 diopters or less
排除标准
- •Use of systemic or ocular medications that may affect vision
- •Uncontrolled systemic or recurrent ocular disease
- •Requiring an intraocular lens <15.0 or >26.0 diopters
- •Abnormal results with the Farnsworth-Munsell D-15 and/or Ishihara color plates
- •History of ocular trauma or prior ocular surgery
- •Known pathology that may affect visual acuity or visual field
- •Corneal abnormalities
- •Pupil abnormalities
- •Capsule or zonular abnormalities
研究组 & 干预措施
ZV9003
modified light transmission intraocular lens
干预措施: modified light transmission intraocular lens (Device)
ZA9003
monofocal acrylic intraocular lens
干预措施: monofocal acrylic intraocular lens (Device)
结局指标
主要结局
Best Corrected Distance Visual Acuity
时间窗: One year
Snellen Equivalent visual acuity of 20/40 or better
Uncorrected Distance Visual Acuity
时间窗: One Year
Snellen Equivalent of 20/40 or better at one year
次要结局
- Contrast Sensitivity(4-6 months)
- Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent".(One Year)