Identification of Minimum Focal Points in Vision Curve Formation After Pseudophakic Presbyopia Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Visual acuity assessment
研究概览
简要总结
The primary objective of this study is to identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (AoC) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated pseudophakic presbyopia surgery.
详细描述
This is a prospective, non-inferiority trial. 80 participants that underwent uncomplicated pseudophakic presbyopia surgery with bilateral premium intraocular lenses (IOL) implantation will be recruited, and their postoperative Visual Curves (VAC) will be evaluated for nine distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). Then, using polynomial and spline interpolation methods on the measured data, the aim is to generate a unique polynomial of degree ninc -1 that satisfies all data points.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age over 40,
- •previous bilateral premium cataract surgery,
- •best corrected visual acuity (BCVA) < 0,2 logMAR
排除标准
- •taking topical medication to reduce intraocular pressure (IOP),
- •macular diseases,
- •corneal diseases,
- •inability to understand the procedure,
- •postoperative astigmatism >1.50 diopters,
- •postoperative clouding of the posterior capsule
结局指标
主要结局
Visual acuity assessment
时间窗: 6 months
Visual acuity assessment in 9 focal points using DDART chart
Visual curves interpolation
时间窗: 6 months
Visual curves interpolation after visual acuity assessment in 9 focal points
Area of the curve (AOC) assessment
时间窗: 6 months
Calculation of the AOC after visual curve interpolation
次要结局
未报告次要终点
研究者
Georgios Labiris
Professor (Associate) of Democritus University of Thrace
Democritus University of Thrace