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

A single center, ambispective, non comparative, observational study evaluating clinical outcomes of Vivity & Vivity Toric IOL up to 3 months of follow-up after bilateral implantation in an Indian population

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/09/036835

Enrollment

Registered

2021-09-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H251- Age-related nuclear cataract

Interventions

None listed

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Binocular Uncorrected (UCDVA) and Best Corrected Distance Visual Acuity (BCDVA) - 3 months post operatively after 2nd eye surgery (at 6 meters) Timepoint: 3 months post second eye surgery	—

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactSudipto Pakrasi

Medanta

sudipto.pakrasi@gmail.com

Outcome results