CTRI/2018/12/016626尚未招募4 期
An Open-label, Prospective, Multicentre, Single arm, Clinical Study to evaluate the Safety and Effectiveness of Acryfold (An Intraocular Lens manufactured by Appasamy Ocular devices Private ltd., Puducherry) in subjects undergoing cataract surgery
Appasamy Ocular devices Private ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
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 Adult Male or Female Patients
- •3 Calculated IOL is within the range of Investigational IOL
- •4 Clear Intraocular Media other than cataract
- •5 Signed Informed consent form
排除标准
- •1 Previous Intra ocular surgery or Corneal Surgery
- •2 Cataract with Astigmatism more than 1.30D
- •3 Pregnancy and Lactation
- •4 Concurrent participation in another investigational drug or device Investigation study
- •5 Instability of Keratometry or Biometry Measurements
- •Subjects shall be discontinued when certain conditions are present at the time of Surgery, Including
- •1 Zonular Instability
- •2 Need for iris Implantation
- •3 Capsular Fibrosis or Other opacity
- •4 Inability to fixate IOL in desired position
- •5 Vitreous loss
- •In such cases the subject shall be followed until the condition has stabilized
研究者
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