CTRI/2022/01/039593尚未招募不适用
Prospective, open-label, single-arm, multicentre, observational, post-marketing clinical study to evaluate safety and performance of Toric hydrophilic Acrylic Intraocular Lens (IOL) (Omni Lens Pvt. Ltd.) in patients who require IOL implantation during routine cataract surgery.
Omni Lens Pvt Ltd1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2022年1月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Best-Corrected Distance Visual Acuity (BCDVA)
研究概览
简要总结
Prospective, open-label, single-arm, multicentre, observational, post-marketingclinical study to evaluate safety and performance of Toric hydrophilic AcrylicIntraocular Lens (IOL) (Omni Lens Pvt. Ltd.) in patients who require IOLimplantation during routine cataract surgery.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient aged greater than or equal to 40 at the time of enrolment
- •A patient who receive Toric Hydrophilic Acrylic IOL (Omni Lens Pvt.
- •Ltd.) as per the instruction mentioned in instructions for use (IFU) of the study device during routine cataract surgery
- •Clear intraocular media other than cataract
- •Calculated IOL power is within the range of the Study device
- •Corneal astigmatism greater than equal to 0.75 D and less than equal to 6.00 D
- •Dilated pupil size large enough to visualize TIOL axis markings postoperatively
- •The patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent
- •The patient is willing to comply with protocol specified follow-up Evaluations.
排除标准
- •Patient with contraindications for TIOL mentioned in the IFU of the study device
- •Previous intraocular or corneal surgery
- •Traumatic cataract
- •Pregnancy or lactation
- •Instability of keratometry or biometry measurements
- •Irregular astigmatism
- •Currently participating in another clinical study with experimental drugs or devices
- •Unsuitable for study participation for any other reason, as determined by Investigators clinical judgment (reason to be documented on CRF)
- •Active SARS-CoV-2 infection known to Patient at the time of enrolment in the study/ patients having signs and symptoms of SARSCoV- 2 infection at the time of enrolment Patients shall be discontinued when certain conditions are present at the time of surgery, including:1 zonular instability; need for iris manipulation; capsular fibrosis or other opacity and inability to fixate IOL in the desired position.
- •In such cases, the patient shall be followed until the condition has stabilized.
结局指标
主要结局
Best-Corrected Distance Visual Acuity (BCDVA)
时间窗: [Time frame: visit 4]
次要结局
- 1. Reduction in cylindrical power of the eye [Time frame: visit 4,(visit 5])
研究者
研究点 (1)
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