CTRI/2022/08/044802招募中4 期
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
- 4 期
- 状态
- 招募中
- 发起方
- one
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Age 18 year or greater
- •2. Cataract
- •3. Calculated IOL power is within the range of the study IOLs.
- •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
- •7. Patient willing to come for all post-operative follow-up
- •8. 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
- •1. Previous intraocular or corneal surgery
- •2. Traumatic cataract
- •3. Pregnancy
- •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.
- •11. Patient suffering from Corneal dystrophy or endothelial insufficiency.
- •12. Patient having active ocular diseases (active diabetic retinopathy, uncontrolled glaucoma)
研究者
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