A Prospective, single arm, multicenter, clinical study of EYECRYL PLUS (ASHFY600) intraocular lens to assess the performance and safety in patients undergoing cataract surgery.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 375
- 试验地点
- 3
- 主要终点
- Percentage of subject achieving distance corrected visual acuity of 0.3 logMAR or better at 12 months post operatively.
研究概览
简要总结
Cataract surgery with intraocular lens implantation is one of the most commonly performed surgical procedures worldwide. The World Health Organization predicts that an estimated 32 million cataract surgeries will be performed globally in 2020.
A cataract is a clouding or opacification of the normally clear lens of the eye or its capsule surrounding transparent membrane that obscures the passage of light through the lens to the retina of the eye. This blinding disease can affect infants, adults, and older people, but it predominates the latter group. It can be bilateral and vary in severity. The disease process progresses gradually without affecting daily activities early on, but with time, especially after the fourth or fifth decade, the cataract will eventually mature, making the lens completely opaque to light interfering with routine activities. Cataracts are a significant cause of blindness worldwide. Treatment options include correction with refractive glasses only at earlier stages, and if cataract mature enough to interfere with routine activities, surgery may be advised, which is very fruitful.
EYECRYL PLUS ASHFY600 is a Monofocal Hydrophobic natural yellow Acrylic Foldable Intraocular Lens. Eyecryl hydrophobic intraocular lenses IOL are acrylic foldable single piece posterior chamber IOLs. These IOLs are designed to be surgically implanted in the human eye as a replacement for the natural crystalline lens
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Age 18 year or greater 2 Cataract 3 Calculated IOL power is within the range of the investigational IOL.
- •4 Given consent to use device related data for scientific purpose 5 Clear intraocular media other than cataract 6 Patient willing to participate and sign informed consent to participate in study and to use device related data for scientific purpose 7 Patient willing to come for all post-operative follow-up.
排除标准
- •1 Previous intraocular or corneal surgery 2 Traumatic cataract 3 Pregnancy or lactation 4 Concurrent participation or participation in the last 30 days in any other clinical trial 5 Irregular astigmatism 6 Instability of keratometry or biometry measurements 7 Vulnerable subject.
- •8 Patients receiving chloroquine treatment.
- •9 Patient having Microphthalmia.
- •10 Patient having Chronic Uveitis.
结局指标
主要结局
Percentage of subject achieving distance corrected visual acuity of 0.3 logMAR or better at 12 months post operatively.
时间窗: 12 Month Post operatively
次要结局
- Percentage of best-case subjects achieving best corrected distance visual acuity of 0.3 logMAR or better at 12 months post operatively.(12 Month Post operatively)
研究者
Dr Uday Gajiwala
Tejas eye hospital