Prospective, open-label, single-arm, multicentre, observational, postmarketing clinical study to evaluate safety and performance of multifocal hydrophobic acrylic foldable intraocular lens (IOL) (Omni Lens Pvt. Ltd.) in patients who require IOL implantation during routine cataract surgery. - NA

Omni Lens Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年1月9日

试验速览

暂无简介。

•1. Patient aged greater than or equal to 40 years at the time of enrolment
•2. A patient who receive multifocal hydrophobic acrylic foldable IOL (Omni Lens Pvt. Ltd.) as per the instruction mentioned in instructions
•for use (IFU) of the study device during routine cataract surgery
•3. Clear intraocular media other than cataract
•4. Calculated IOL power is within the range of the study device
•5. The patient or his/her legally authorized representative (if applicable)
•agrees to provide written informed consent
•6. The patient is willing to comply with protocol specified follow-up
•evaluations

•1. Patient with contraindications for Multifocal IOL mentioned in the
•IFU of the study device
•2. previous intraocular or corneal surgery
•3. traumatic cataract
•4. pregnancy or lactation
•5. instability of keratometry or biometry measurements
•6. irregular astigmatism
•7. more than 1 D of pre-operative corneal astigmatism
•8. Currently participating in another clinical study with experimental
•drugs or devices
•9. Unsuitable for study participation for any other reason, as determined
•by Investigators clinical judgment (reason to be documented on CRF)
•10. 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:
•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.

发起方

Omni Lens Pvt Ltd