A clinical study of EYECRYL™ PLUS (600) intraocular lens in patients undergoing cataract surgery

Phase 4

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

• Registration Number: CTRI/2024/02/062688
• Lead Sponsor: Biotech vision care pvt ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

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

investigational IOL.

4. Clear intraocular media other than cataract

5. Patient willing to participate and sign informed consent to

participate in study and to use device related data for

scientific purpose

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

7. 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

5. Vulnerable subject.

6. Patients receiving chloroquine treatment.

7. Patient having Microphthalmia.

8. Patient having Chronic Uveitis.

9. Patient suffering from corneal dystrophy or endothelial

insufficiency.

10. Patient having active ocular diseases (active diabetic

retinopathy, uncontrolled glaucoma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of eyes that will achieve distance <br/ ><br>uncorrected visual acuity within (0.3 logMAR or <br/ ><br>better) at 180 days post operatively. <br/ ><br>Timepoint: Percentage of eyes that will achieve distance <br/ ><br>uncorrected visual acuity within (0.3 logMAR or <br/ ><br>better) at 180 days post operatively. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To assess safety of EYECRYL™ PLUS 600 <br/ ><br>intraocular lens in patients undergoing cataract <br/ ><br>surgery. <br/ ><br>Timepoint: Time frame: Preoperative, 7-14 days, 30-60 <br/ ><br>days, 120-180 days, 330-420 days, 630-780 <br/ ><br>days and 990-1140 days post operatively.