A clinical study of EYECRYLâ?¢ PLUS (ASHFY600) intraocular lens in patients undergoing cataract surgery.

Phase 4

Conditions: Health Condition 1: H251- Age-related nuclear cataract

Registration Number: CTRI/2022/08/044802

Lead Sponsor: one

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Age 18 year or greater

2. Cataract

3. Calculated IOL power is within the range of the study IOLs.

4. Given consent to use device related data for scientific purpose

5. Clear intraocular media other than cataract

6. Patient willing to participate and sign informed consent

7. Patient willing to come for all post-operative follow-up

8. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study

Exclusion Criteria

1. Previous intraocular or corneal surgery

2. Traumatic cataract

3. Pregnancy

4. Concurrent participation or participation in the last 30 days in any other clinical trial

5. Irregular astigmatism

6. Instability of keratometry or biometry measurements

7. Vulnerable subject.

8. Patients receiving chloroquine treatment.

9. Patient having Microphthalmia.

10. Patient having Chronic Uveitis.

11. Patient suffering from Corneal dystrophy or endothelial insufficiency.

12. Patient having active ocular diseases (active diabetic retinopathy, uncontrolled glaucoma)

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br/ ><br>Primary outcome: <br/ ><br>1. Monocular uncorrected distance visual acuity (UCVA) <br/ ><br>2. Distance corrected visual acuity (BCVA) <br/ ><br> <br/ ><br>Secondary outcome: <br/ ><br>1. Contrast sensitivity <br/ ><br>2. Adverse events <br/ ><br>Timepoint: Time frame: Preoperative, 1-2days, 7-14 days, 30-60 days, 120-180 days, <br/ ><br>330-420 days, 630-780 days and 990-1140 days post <br/ ><br>operatively

Secondary Outcome Measures

Name	Time	Method
1. Contrast sensitivity <br/ ><br>2. Adverse events <br/ ><br>Timepoint: Pre-operative, 1-2day, 7-14 day, 30-60 day, 120-180 day and 330-420 day, 630-780 days, 990-1140 days post operatively