CTRI/2024/12/078539尚未招募Unknown
Prospective single arm, post marketing clinical study of REPER RPR-13 Hydrophobic Intraocular Lens to assess performance and safety in patients undergoing cataract surgery
Rayner Surgical India Pvt Ltd formerly Surgicon Healthcare Pvt Ltd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1月4日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess the intraoperative safety and performance of the Intraouclar Lens.
研究概览
简要总结
Hydrophobic Intraocular lenses are routinely implanted worldwide, REPER RPR-13 are Hydrophobic monofocal intraocular lenses, similar to normal hyrodphobic lenses manufactured, however the manufacturer REPER NN, being located in Russia and due to sanctions in Russia, the manuacturer is unable to obtain a free sale certificate in any GHTF Countries, hence this clinical trial to evaluate the safety and efficary of RPR-13 Intraocular lens,
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults, Subjects who have already undergone cataract surgery using IOL, Calculated IOL power is within the range of the investigational IOL (+ 10.0 to 30.0 Diopter), Subjects available after contact and willing to come for follow up during the clinical study, Subjects with signed informed consent, Subject having clear intraocular media other than cataract.
排除标准
- •Patients unwilling to participate in the study, subject with previous intraocular or corneal surgery, Subject having traumatic cataract, Pregnancy or lactation, Concurrent participation in another drug or device investigation, Instability of keratometry or biometry measurements, Irregular astigmatism.
结局指标
主要结局
To assess the intraoperative safety and performance of the Intraouclar Lens.
时间窗: 2 Months, 6 Months, 12 Months
次要结局
- To determint the prescence of lens related adverse events, residual risks and visual acuity in the individuals on whom the device was implanted(2 months, 6 months, 1 year)
研究者
Uday Gajiwala
Tejas Eye Hospital
研究点 (1)
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