DRKS00025969尚未招募4 期
A prospective, multicenter clinical study comparing outcomes of two trifocal toric intraocular lens - BTVCPL-TRITORIC-2019-18
Biotech Europe Meditech Inc. Ltd.0 个研究点目标入组 84 人开始时间: 2021年8月4日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 one（—）
- 性别
- All
入选标准
- •1. Age of patient >21 Years
- •2. Patient diagnosed with cataract.
- •3. Patient must have preoperative regular corneal astigmatism between 0.75 to 4.5 D as per corneal topography or keratometry
- •4. Calculated IOL power is within the range of investigational IOLs.
- •5. Patient willing to sign inform consent form.
- •6. Clear intraocular media other than cataract.
- •7. Female participants of childbearing potential must be willing to ensure that they use effective contraception during the study.
排除标准
- •1. Previous intraocular or corneal surgery.
- •2. Traumatic cataract
- •3. Pregnancy (as stated by patient) or lactation.
- •4. Concurrent participation in another drug or device investigation.
- •5. Irregular astigmatism.
- •6. Patient receiving chlorquine treatment.
- •7. Subjects with any systemic disease that could increase operative risk or confound the outcome.
- •8. Active ocular disease in the operative eye other than cataract.
- •9. Vulnerable subjects as defined in section 12.3.9.
- •10. Corneal Astigmatism > 4.5 D
研究者
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