NCT03371576已完成不适用
Comparison of Two Toric IOL´s With Different Haptic Design: Optical Quality After 1 Year
Hospital Hietzing0 个研究点目标入组 60 人开始时间: 2012年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- uncorrected visual acuity
研究概览
简要总结
Purpose: Comparison of two torical intraocular lenses with differents haptic design in patients with cataract.
Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes the Tecnis torical IOL (Abbott Medical Optics) or the AT Torbi torical 709 MB IOL (Zeiss Medical AG) were randomly implanted. Three months after surgery visual acuity, rotation stability and astigmatism correction were evaluated.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age related cataract on both eyes
- •Corneal astigmatism 1,0- 4,0 D
- •Potential postoperative visus 1,0
- •No other ocular pathology as cataract
- •Age 18 - 80
- •Written informed consent to surgery and participation in the study
排除标准
- •Pregnancy, breastfeeding
- •Amblyopy, diabetic retinopathy, uveitis or other relevant ophthalmologic diseases
- •Optical media disturbances due to: corneal and vitreal opacity, PEX
- •Irregular astigmatism measured with corneal topography (Visante-omni), keratoconus
- •≥ 10 degrees difference between the axis of keratometry measurement of the IOL Master and the simulated K reading of the corneal topograph (Visante-omni)
- •Trauma, ocular surgery performed within 6 months
- •Traumatic cataract
- •Potential postoperative visus under 1,0
结局指标
主要结局
uncorrected visual acuity
时间窗: 1 year
visual acuity in logMARon an ETDRS Chart
次要结局
未报告次要终点
研究者
Michael Lasta
Principal investigator
Hospital Hietzing
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