The Purpose of This Research is to Assess Vivity Toric IOL Rotational Stability at the End of Surgery, Post op 1 Day, Post op 1 Week and Post op 4 Weeks. Participants in This Research Study Are 45 Years of Age or Older and Have Planned Implantation in at Least One Eye With an Acrysof IQ Vivity Extended Vision Toric IOL.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Rotational stability of Vivity Toric IOL.
研究概览
简要总结
The purpose of this research is to assess the rotational stability of the AcrySof IQ Vivity Extended Vision Toric IOL and Refractive Visual outcome.
详细描述
Assessment of the rotational stability and Refractive Visual Outcome of the AcrySof IQ Vivity Extended Vision Toric IOL at the end of surgery, post op 1 day, post op 1 week and post op 4 weeks. Participants in this research study are 45 years of age or older and have planned implantation in at least one 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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects undergoing cataract extraction with intraocular lens implantation.
- •Age: 45 years and older.
- •Willing and able to comply with scheduled visits and other study procedures.
- •Subjects who require an IOL power in the range of +15.0 D to +25.0 D.
- •Subjects with regular corneal astigmatism that can be treated with T3-T
- •Have good ocular health, with no pathology that compromises visual acuity (Outside of residual refractive error and cataract)
- •Potential postoperative visual acuity of 0.2 logMAR/ETDRS (20/32 Snellen) or better in both eyes.
排除标准
- •Glaucoma.
- •Clinically significant corneal dystrophy.
- •Previous corneal refractive surgery (i.e LASIK, PRK, RK)
- •Pupil abnormalities.
- •Concurrent infectious/non-infectious uveitis.
- •History of chronic intraocular inflammation.
- •Visually significant macular disease.
- •History of retinal detachment.
研究组 & 干预措施
vivity toric IOL implantation arm
vivity toric intraocular lens will be implanted in one eye and undergo digital imaging intra op and post op to evaluate for toric intraocular lens rotational stability.
干预措施: Alcon Vivity toric intra ocular lens (Device)
结局指标
主要结局
Rotational stability of Vivity Toric IOL.
时间窗: Five months
Rotational stability of Vivity Toric IOL will be measured at post op 1 day, post op 1 week and post op 4 weeks.
次要结局
- Percentage of eyes with residual refractive astigmatism, absolute residual astigmatism prediction error, and monocular distance and intermediate visual acuities.(Five months)
研究者
Kevin Barber
Ophthalmologist
Central Florida Eye Specialists, LLC