A Prospective, single arm, multicentric, clinical study of EYECRYL PLUS (600) intraocular lens to assess 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
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. 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 600 is a Monofocal Hydrophilic Acrylic Foldable Intraocular Lens. Eyecryl hydrophilic intraocular lenses are acrylic foldable single piece multi piece posterior chamber IOL. These IOL 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 Adult patient, 18 years old or older will be enrolled in the study 2 Patient with cataract 3 Calculated IOL power is within the range of the study IOL 4 Patients must sign and be given a copy of the written Informed Consent form 5 Clear intraocular media other than cataract 6 Patient willing to undergo the investigations and comply with the follow-up schedule.
排除标准
- •1 Previous intraocular or corneal surgery 2 Pregnancy or lactation 3 Concurrent participation or participation in the last 30 days in any other clinical trial 4 Irregular astigmatism 5 instability of keratometry or biometry measurements 6 Vulnerable subjects 7 Patients receiving chloroquine treatment.
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 months 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 months post operatively.)
研究者
Dr Uday Gajiwala
Tejas eye hospital