Prospective, single arm, post-marketing clinical study of EYECRYLâ„¢ 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
- 850
- 试验地点
- 1
- 主要终点
- Percentage of eyes that will achieve distance
研究概览
简要总结
The objectives of this study are to evaluate safety and performance of EYECRYLâ„¢ PLUS (600), a Monofocal Hydrophillic clear Acrylic Foldable Intraocular Lens in patients undergoing cataract surgery, to evaluate monocular uncorrected distance visual acuity (UCVA) and distance corrected visual acuity (BCVA) under photophic conditions and to measure the Contrast Sensitivity
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 year or greater
- •Calculated IOL power is within the range of the investigational IOL.
- •Clear intraocular media other than cataract
- •Patient willing to participate and sign informed consent to participate in study and to use device related data for scientific purpose
- •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
- •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
Percentage of eyes that will achieve distance
时间窗: Percentage of eyes that will achieve distance | uncorrected visual acuity within (0.3 logMAR or | better) at 180 days post operatively.
uncorrected visual acuity within (0.3 logMAR or
时间窗: Percentage of eyes that will achieve distance | uncorrected visual acuity within (0.3 logMAR or | better) at 180 days post operatively.
better) at 180 days post operatively.
时间窗: Percentage of eyes that will achieve distance | uncorrected visual acuity within (0.3 logMAR or | better) at 180 days post operatively.
次要结局
- To assess safety of EYECRYLâ„¢ PLUS 600(intraocular lens in patients undergoing cataract)
研究者
DR UDAY GAJIWALA
Tejas eye hospital