A trial comparing two trifocal toric intraocular lens

Phase 4

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

• Registration Number: CTRI/2022/02/040590
• Lead Sponsor: Biotech Healthcare Holdings GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

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

Inclusion Criteria

1.Age of patient >21 years

2.Patient diagnosed with cataract

3.Patient must have preoperative regular corneal astigmatism between 0.75 to 4.5D as per corneal topography or keratometry

4.Calculated IOL Power is within the range of the investigational IOLs

5.Patient willing to sing informed consent form

6.Clear intraocular media other than cataract

7.Female participants of child bearing potential must be willing to ensure that they use effective contraception during the study

Exclusion Criteria

1.Previous intraocular or corneal surgery

2.Traumatic Cataract.

3.Pregnancy (as stated by patient) or lactation

4.Concurrent participation in another drug or device investigation

5.Irregular Astigmatism

6.Patient receiving chlorquine treatment

7.Subjects with any systemic disease that could increase operative risk or confound the outcome

8.Active ocular disease in the operative eye other than cataract

9.Vulnerable subjects

10.Corneal Astigmatism >4.5D

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the distance-corrected intermediate visual acuity between the two trifocal toric intraocular lensesTimepoint: � Post-operative 1 Day <br/ ><br>� Post-operative 1 Week ± 2 Days <br/ ><br>� Post-operative 1 Month ± 7 Days <br/ ><br>� Post-operative 3 Months ± 7 Days <br/ ><br>� Post-operative 6 Months ± 14 Days <br/ ><br>� Post-operative 12 Months ± 30 Days <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To assess and compare the safety of two trifocal toric intraocular lensesTimepoint: � Post-operative 1 Day <br/ ><br>� Post-operative 1 Week ± 2 Days <br/ ><br>� Post-operative 1 Month ± 7 Days <br/ ><br>� Post-operative 3 Months ± 7 Days <br/ ><br>� Post-operative 6 Months ± 14 Days <br/ ><br>� Post-operative 12 Months ± 30 Days <br/ ><br>