Safety and performance of Intraocular Lens
- Conditions
- Health Condition 1: Z961- Presence of intraocular lens
- Registration Number
- CTRI/2022/01/039593
- Lead Sponsor
- Omni Lens Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. 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
1. 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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best-Corrected Distance Visual Acuity (BCDVA)Timepoint: [Time frame: visit 4]
- Secondary Outcome Measures
Name Time Method 1. Reduction in cylindrical power of the eye [Time frame: visit 4, <br/ ><br>visit 5] <br/ ><br>2. Rotational stability [Time frame: visit 4] - Rotational stability will be evaluated by IOL axis mark rotation at <br/ ><br>visit 4. <br/ ><br>3. Best-Corrected Distance Visual Acuity (BCDVA) compared to <br/ ><br>historical Data of EN ISO 11979-7:2018, Annex E (Table E.3 <br/ ><br>and E.4) [Time frame: Pre-op, visit 2, visit 3, visit 4, visit 5] <br/ ><br>4. Adverse event rates [Time frame: Baseline, visit 1, visit 2, visit 3, <br/ ><br>visit 4, visit 5] <br/ ><br>Timepoint: [Time frame: visit 4]