Safety and performance of Intraocular Lens

Not yet recruiting

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Patient aged greater than or equal to 40 at the time of enrolment 2.
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 3.
Clear intraocular media other than cataract 4.
Calculated IOL power is within the range of the Study device 5.
Corneal astigmatism greater than equal to 0.75 D and less than equal to 6.00 D 6.
Dilated pupil size large enough to visualize TIOL axis markings postoperatively 7.
The patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent 8.
The patient is willing to comply with protocol specified follow-up Evaluations.

Exclusion Criteria

Patient with contraindications for TIOL 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.
Currently participating in another clinical study with experimental drugs or devices 8.
Unsuitable for study participation for any other reason, as determined by Investigators clinical judgment (reason to be documented on CRF) 9.
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.

Primary Outcome Measures

Name	Time	Method
Best-Corrected Distance Visual Acuity (BCDVA)	[Time frame: visit 4]

Secondary Outcome Measures

Name	Time	Method
1. Reduction in cylindrical power of the eye [Time frame: visit 4,	visit 5]

Locations (1): Tejas Eye Hospital Run by Divyajyoti Trust
🇮🇳
Surat, GUJARAT, India
Tejas Eye Hospital Run by Divyajyoti Trust
🇮🇳Surat, GUJARAT, India
Dr Anshulee Sood
Principal investigator
8447526636
anshuleesood@gmail.com
Dr Uday R Gajiwala
Principal investigator
9426125947
divyajyoti.icare@gmail.com
Dr Uma Shroff
Principal investigator
9426125947
divyajyoti.icare@gmail.com