Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric & PODEYE Toric
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- Change of axial intraocular lens position
研究概览
简要总结
The investigational devices are approved intraocular lenses (IOL) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Within the study, three different IOLs will be investigated and separately evaluated. Cataract surgery with IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be postoperative refraction, visual acuity, slitlamp examination, and rotation of the IOL within 1 hour, 1 week, 1 month and 4-7 months.
In the Alcon Clareon toric, RayOne EMV toric and PODEYE Toric group, patients receive a toric IOL according to their preoperative astigmatism
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
- None
入排标准
- 年龄范围
- 45 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uni- or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
- •Age: 45 to 95
- •Need for spherical IOL correction between 10.00 and 30.00 D
- •Need for spherical IOL correction between +6.00 and +30.00 D (Alcon Clareon toric group)
- •Need for spherical IOL correction between +10.00 and +25.00 D (Rayner RayOne EMV toric group)
- •Preoperative pupil dilation in mydriasis ≥ 7.0 mm (Hoya, Rayner groups)
- •Astigmatism of at least 1.0 Diopters (Alcon Clareon toric and Rayner RayOne EMV toric groups and PODEYE Toric)
- •Pupil dilation >5.5mm (Alcon Clareon toric Rayner RayOne EMV toric group)
排除标准
- •Preceding ocular surgery or trauma
- •Recurrent intraocular inflammation of unknown etiology
- •Uncontrolled glaucoma
- •Uncontrolled systemic or ocular disease
- •Blind fellow eye
- •Microphthalmus
- •Corneal abnormality (Corneal scaring)
- •History of uveitis/iritis
- •Iris neovascularization
- •Proliferative diabetic retinopathy
- •Pregnancy
- •Lactation
- •Females of childbearing age will be asked if pregnancy is possible
结局指标
主要结局
Change of axial intraocular lens position
时间窗: 7 months
Change in axis position of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric or PODEYE Toric from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)
次要结局
- Decentration(7 months)
- Tilt(7 months)
- Anterior chamber depth(1 month)
- Best corrected visual acuity (BCVA)(7 months)
- UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups(7 months)
研究者
Rupert Menapace
Ao.Univ.Prof.Dr. Rupert Menapace
Medical University of Vienna