Safety and performance of Intraocular Lens

Not Applicable

• Conditions: Health Condition 1: Z961- Presence of intraocular lens

• Registration Number: CTRI/2022/01/039594
• Lead Sponsor: Omni Lens Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean CDVA (4 m)Timepoint: [Time frame: visit 3]

Secondary Outcome Measures

Name	Time	Method
1. Mean CDVA (4 m), mean DCIVA (60 cm) and mean DCNVA <br/ ><br>(40 cm) [Time frame: Pre-op, visit 2, visit 3, visit 4, visit 5] <br/ ><br>2. Mean UDVA (4 m), mean UIVA (60 cm) and mean UNVA (40 <br/ ><br>cm) [Time frame: Pre-op, visit 2, visit 3, visit 4, visit 5] <br/ ><br>3. Secondary surgical intervention rate [Time frame: visit 2, visit <br/ ><br>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 2, visit <br/ ><br>3, visit 4, visit 5]