Evaluating the Need for Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Clinically significant difference in results obtained for tori iol implantation when using IA
研究概览
简要总结
To determine clinically significant difference in results obtained from cataract surgery using IA. One eye will receive aphakic measurements only and the fellow eye will receive aphakic and then pseudophakic measurements when implanting a toric IOL.
详细描述
To determine if there is a clinically significant difference in the results obtained for the toric IOL implantation when using IA to measure the aphakic eye only and when using IA to measure the aphakic eye and then the pseudophakic eye, with toric IOL implantation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •willing and able to understand and sign an informed consent
- •willing and able to attend all study visits
- •presenting for uncomplicated bilateral cataract surgery and have an interest in a toric iol
- •have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error)
- •have visually significant cataracts
- •have regular corneal astigmatism of 1.0D to 5.0D in both eyes with a difference between eyes of 1.0D or less
- •have potential post operative acuity of 20/25 or better
排除标准
- •corneal pathology
- •amblyopia
- •prior corneal refractive surgery or other refractive surgery
- •previous anterior or posterior chamber surgery that the investigator feels may compromise visual outcomes
- •Diabetic retinopathy if the investigator feels this will compromise visual outcomes
- •macular degeneration
- •history of retinal detachment
- •irregular astigmatism or keratoconus
- •strabismus
- •if in the surgeon's opinion the subject is not an appropriate candidate for iol implantation
- •subjects who have an acute or chronic disease or illness that would confound the results of this investigation
结局指标
主要结局
Clinically significant difference in results obtained for tori iol implantation when using IA
时间窗: 30 days
Difference in magnitude of residual refractive astigmatism between groups Percentage of eyes with 0.50D or less of postoperative residual refractive astigmatism at 1 month post-op in each sub-group * Percentage of eyes within 0.50D of intended spherical equivalent * Sub-group analysis: * Vector analysis of the effects of any toric IOL realignment suggested by pseudophakic IA (i.e. was it likely to improve or worsen residual refractive astigmatism and/or UCVA)
次要结局
未报告次要终点