OcuMap – A surgical Medical Decision-Making tool for Intraocular Lens Selection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- • Phase 1: Ocumap data feeding phase: Validation of Ocumap engine after training and validation using subset.
研究概览
简要总结
All data generated as a result of this assessment will be regarded as confidential, until appropriate analysis and review by the Investigator(s) are completed. The results of the assessment may be published or presented by the Investigator(s) after the review and such that confidential or proprietary information is not disclosed.
Prior to publication or presentation, a copy of the final text should be forwarded to the Investigator(s) or its designee, for comment. Such comments shall aim to ensure the scientific integrity of the proposed publications and/or presentations and ensure that the data and material and activities receive fair, accurate, and reasonable presentation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients presenting for cataract surgery.
排除标准
- 未提供
结局指标
主要结局
• Phase 1: Ocumap data feeding phase: Validation of Ocumap engine after training and validation using subset.
时间窗: Screening visit, Month 3 after implant
• Phase 2: Ocumap recommendations: Proportion of patients receiving IOL such as advanced monofocal, extended range of vision, Trifocal or Bifocal intraocular lens ; toric and non-toric versions of each lens included
时间窗: Screening visit, Month 3 after implant
次要结局
- • Surgeon time with patient during preoperative visit(s)(• Surgeon satisfaction with Ocumap, including)
研究者
Dr Sathyan Parthasarathi
SATHYAN EYE CARE HOSPITAL & COIMBATORE GLAUCOMA FOUNDATION,