Evaluation of Binocular Visual Acuity in Myopic Cataract Patients Using Trifocal Intraocular Lens : a 2 Years Prospective, Observational, Multi-center Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Axial length (AL)
研究概览
简要总结
The PanOptix trifocal IOL is a new trifocal intraocular lens which is proved to provide good range of vision for distance, intermediate and near and good visual quality in cataract patients with normal axial length. But whether it can get the same visual quality in myopia is still unknown
详细描述
There are a few publications of multi-focal IOLs on Chinese patients with high myopia. From published papers, it is known that performance of multifocal IOLs is satisfied in myopic patients. However there is no publication to investigate PanOptix in moderate and high myopic patients. So it is imperative to demonstrate good performance of PanOptix in those special patients. The purpose of this study is to assess visual performance and patient satisfaction after the implantation of PanOptix in myopic patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Axial myopic patients（Refractive condition match the axial length after eliminate the nuclear cataract induced myopia factor）
- •Corneal astigmatism <1.0D (IOL-Master 500/700, Carl Zeiss Meditec, Jena, Germany);
- •Eyes with pupil diameter>2.5 mm (Photopic) and<6 mm (Mesopic) (Pentacam HR, Oculus Optikgerate GmbH);
- •Eyes with angle kappa<0.50 mm (Pentacam HR);
- •Eyes with corneal spherical aberration<0.50 (Pentacam HR)
排除标准
- •Irregular corneal astigmatism
- •Any retinal disease, macular disease(Including myopic MD and retinal diseases) could affect VA, glaucoma and other severe intraocular diseases
- •Moderate-severe dry eye
- •Amblyopia（BCDVA<0.7 before cataract appears）
- •Patients having difficulties with examinations or 3 months' follow-up.
结局指标
主要结局
Axial length (AL)
时间窗: 1 minute
Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)
Uncorrected distance visual acuity
时间窗: 10 minutes
Uncorrected distance visual acuity (4m) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).
Uncorrected intermediate visual acuity
时间窗: 10 minutes
Uncorrected intermediate visual acuity (60cm) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA)
Uncorrected near visual acuity
时间窗: 10 minutes
Uncorrected near visual acuity (40cm) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA).
contrast sensitivity
时间窗: 30 minutes
Binocular contrast sensitivity was measured at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the functional acuity contrast test(Test SV-1000) of the CC-100 HW 5.0 Series system
次要结局
未报告次要终点