A real world study of a new extended depth of focus IOL in an Indian populatio

Phase 4

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

• Registration Number: CTRI/2021/09/036835
• Lead Sponsor: Medanta Institute of Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

Adult subjects 18 years or older with age related cataract with NS grade I to IV on the LOCS III.

Subject is willing and able to provide informed consent personally or by legal representative.

Subject follow-up is expected to be possible during the study.

Bilateral implant of either ACRYSOF Vivity or ACRYSOF Vivity Toric.

Documented medical history and required preoperative baseline information available for retrospective data collection.

Exclusion Criteria

Patients with any pre-existing ocular co-morbidities/prior refractive surgery would be excluded.

Patients undergoing corneal refractive surgery post Vivity IOL implantation,

Patients with manifest refraction(Spherical Equivalent) >0.75 D post-operatively and

Patients with pregnancy at the time of enrolment would also be excluded.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Binocular Uncorrected (UCDVA) and Best Corrected Distance Visual Acuity (BCDVA) - 3 months post operatively after 2nd eye surgery (at 6 meters) <br/ ><br>Timepoint: 3 months post second eye surgery <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Binocular UCDVA and BCDVA at 1 month post operatively after 2nd eye surgery (at 6 meters) <br/ ><br>Binocular UCIVA and DCIVA at 1 month & 3 months post-operatively after 2nd eye surgery (at 66cm) <br/ ><br>Binocular UCNVA and DCNVA at 1 month & 3 months post-operatively after 2nd eye surgery (at 40cm) <br/ ><br>Binocular Defocus curve performance at 3 months post-operatively after 2nd eye surgery <br/ ><br>Binocular Contrast Sensitivity testing using Peli-Robsons chart at 3 months post-operatively after 2nd eye surgery <br/ ><br>Visual disturbances assessed by McAlinden questionnaire at 3 months post-operatively after 2nd eye surgery <br/ ><br>Timepoint: 1 month & 3 months post operatively after 2nd eye surgery