Prospective single arm, post-marketing clinical study of EYECRYLâ„¢ PLUS (ASHFY600) intraocular lens to assess performance and safety in patients undergoing cataract surgery.
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 490
- 试验地点
- 1
- 主要终点
- Primary outcome:
研究概览
简要总结
The objectives of this study are to evaluate safety andperformance of Eyecryl Plus intraocular lens in patients undergoing cataractsurgery, to evaluate monocular uncorrected distance visual acuity (UCVA) anddistance corrected visual acuity (BCVA) under photophic conditions and tomeasure the Contrast Sensitivity.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 year or greater
- •Calculated IOL power is within the range of the study IOLs.
- •Given consent to use device related data for scientific purpose
- •Clear intraocular media other than cataract
- •Patient willing to participate and sign informed consent
- •Patient willing to come for all post-operative follow-up
- •Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
排除标准
- •Previous intraocular or corneal surgery
- •Traumatic cataract
- •Pregnancy
- •Concurrent participation or participation in the last 30 days in any other clinical trial
- •Irregular astigmatism
- •Instability of keratometry or biometry measurements
- •Vulnerable subject.
- •Patients receiving chloroquine treatment.
- •Patient having Microphthalmia.
- •Patient having Chronic Uveitis.
- •Patient suffering from Corneal dystrophy or endothelial insufficiency.
- •Patient having active ocular diseases (active diabetic retinopathy, uncontrolled glaucoma).
结局指标
主要结局
Primary outcome:
时间窗: Time frame: Preoperative, 1-2days, 7-14 days, 30-60 days, 120-180 days, | 330-420 days, 630-780 days and 990-1140 days post | operatively
1. Monocular uncorrected distance visual acuity (UCVA)
时间窗: Time frame: Preoperative, 1-2days, 7-14 days, 30-60 days, 120-180 days, | 330-420 days, 630-780 days and 990-1140 days post | operatively
Secondary outcome:
时间窗: Time frame: Preoperative, 1-2days, 7-14 days, 30-60 days, 120-180 days, | 330-420 days, 630-780 days and 990-1140 days post | operatively
1. Contrast sensitivity
时间窗: Time frame: Preoperative, 1-2days, 7-14 days, 30-60 days, 120-180 days, | 330-420 days, 630-780 days and 990-1140 days post | operatively
2. Distance corrected visual acuity (BCVA)
时间窗: Time frame: Preoperative, 1-2days, 7-14 days, 30-60 days, 120-180 days, | 330-420 days, 630-780 days and 990-1140 days post | operatively
2. Adverse events
时间窗: Time frame: Preoperative, 1-2days, 7-14 days, 30-60 days, 120-180 days, | 330-420 days, 630-780 days and 990-1140 days post | operatively
次要结局
- 1. Contrast sensitivity(2. Adverse events)